Device, Digital Image Storage, Radiological
Regulation 892.2010
0510(k)s in 12 months (55 all time)
0recalls in 12 months (19 all time)
4recalls that name a 510(k)
Top companies in LMB
| Company | 510(k)s | Recalls |
|---|---|---|
| Merge Healthcare, Inc. | 0 | 5 |
| Eastman Kodak Company | 4 | 0 |
| Camtronics, Ltd. | 3 | 0 |
| Eigen | 3 | 0 |
| Olympus America, Inc. | 1 | 2 |
| Stryker Imaging | 0 | 3 |
| Andros Analyzers, Inc. | 2 | 0 |
| Base Ten Systems, Inc. | 2 | 0 |
| Ge Healthcare It | 0 | 2 |
| O Tech, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2017 | Merge Healthcare, Inc. iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Terminated |
LMB | None listed |
| Mar 10, 2017 | Merge Healthcare, Inc. iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. Terminated |
LMB | K053281 |
| Sep 6, 2016 | Ge Healthcare It Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. Terminated |
LMB | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data Terminated |
LMB | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. iConnect Enterprise Archive software. Terminated |
LMB | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI.
iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications Terminated |
LMB | None listed |
| Dec 19, 2014 | Ge Healthcare It Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM pr Terminated |
LMB | None listed |
| Aug 10, 2011 | Siemens Medical Solutions USA, Inc LANTIS Oncology Information System (OIS)
Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens.
An oncology digital imaging information management system. Lantis OIS in combination w Terminated |
LMB | None listed |
| May 6, 2011 | Siemens Medical Solutions USA, Inc LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential.
Distributed by Siemens, Concord, Terminated |
LMB | None listed |
| May 10, 2010 | Stryker Endoscopy An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file format Terminated |
LMB | None listed |
| Nov 10, 2009 | Stryker Imaging Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)
Intended use of Guardian Services is to act Terminated |
LMB | None listed |
| Nov 10, 2009 | Stryker Imaging Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice).
The intended us of Guardian is to act as a medical data backup and disast Terminated |
LMB | None listed |
| Nov 9, 2009 | Stryker Imaging Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power).
Intended use is to act as a medical data backup and disaster Terminated |
LMB | None listed |
| Sep 24, 2009 | GE Healthcare Integrated IT Solutions Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The software delivers a scalable and flexible DICOM storage solution fo Terminated |
LMB | None listed |
| Sep 11, 2008 | Stryker Endoscopy Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system. Terminated |
LMB | None listed |
| Apr 8, 2005 | Philips Medical Systems Sales & Service Region No. America Easy Access Image Management System with CL.Net. Terminated |
LMB | K983447 |
| Oct 15, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software Terminated |
LMB | K934888 K934889 |
| Aug 12, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt. Terminated |
LMB | K934888 K934889 |
| Jun 5, 2003 | Canon USA Inc Rational Imaging TM Software, model Ultra 10
PACS System Version 7.1.Xx Terminated |
LMB | None listed |
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