System, Image Processing, Radiological
Regulation 892.2050
48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | None listed |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospi Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hosp Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual Reading Basic SW StandAlone
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual Enterprise SW StandAlone
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual Access Pluse SW, StandAlone
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual Access Software, StandAlone
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions fo Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; Virtual Access Plus SW, Workgroup
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza image processing system
image processing radiological system Terminated |
LLZ | K093612 |
| Nov 6, 2013 | Vital Images, Inc. VitreaCore software. Versions subject to the limitation:
6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as
well as their upgrades, and 6.5.
The VitreaCore (ViTALConnect) system is Terminated |
LLZ | K062154 K071362 |
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