Cabinet, X-Ray System
Regulation 892.1680
0510(k)s in 12 months (27 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MWP
| Company | 510(k)s | Recalls |
|---|---|---|
| Kub Technologies, Inc. | 6 | 0 |
| Faxitron Bioptics, LLC | 5 | 0 |
| Bioptics, Inc. | 4 | 0 |
| Cirdan Imaging Limited | 2 | 0 |
| Compai Healthcare (Suzhou) Co.,Ltd | 2 | 0 |
| Faxitron X-Ray Corp. | 2 | 0 |
| Hologic, Inc. | 2 | 0 |
| Clarix Imaging | 1 | 0 |
| Compai Healthcare (Shenzhen) Co.,Ltd | 1 | 0 |
| Fischer Imaging Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2023 | K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) Compai Healthcare (Suzhou) Co.,Ltd, CN | MWP |
| Apr 24, 2023 | K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) Compai Healthcare (Suzhou) Co.,Ltd, CN | MWP |
| Dec 22, 2021 | K213691 | Solas OR Cirdan Imaging, Ltd., GB | MWP |
| Sep 20, 2021 | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System Kub Technologies, Inc. | MWP |
| Aug 31, 2021 | K210957 | Kubec Xpert 80 Radiography System Kub Technologies, Inc. | MWP |
| Aug 31, 2021 | K210956 | Kubtec Mozart (XPERT42) Kub Technologies, Inc. | MWP |
| Nov 18, 2020 | K202713 | TrueView 100 Pro Compai Healthcare (Shenzhen) Co.,Ltd, CN | MWP |
| Jun 12, 2020 | K200756 | Kubtec Mozart Supra Kub Technologies, Inc. | MWP |
| Dec 27, 2019 | K192939 | Volumetric Specimen Imager Clarix Imaging | MWP |
| Dec 13, 2019 | K193317 | CoreLite X-Ray Specimen Cabinet Cirdan Imaging Limited, GB | MWP |
| Jun 20, 2019 | K183624 | Kubtec Mozart (Xpert42) Kub Technologies, Inc. | MWP |
| Mar 14, 2019 | K183142 | PathVisionXL Faxitron Bioptics, LLC | MWP |
| Jan 10, 2019 | K182727 | Trident HD Specimen Radiography System Hologic, Inc. | MWP |
| May 9, 2018 | K173309 | Faxitron VisionCT Faxitron Bioptics, LLC | MWP |
| Jul 18, 2017 | K170786 | Faxitron Bioptics Speciemen Radiography System Faxitron Bioptics, LLC | MWP |
| Apr 1, 2016 | K153583 | BioVision Plus Faxitron Bioptics, LLC | MWP |
| Sep 25, 2012 | K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM Faxitron Bioptics, LLC | MWP |
| Aug 19, 2011 | K111508 | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 Hologic, Inc. | MWP |
| Jun 16, 2010 | K091928 | 10 X 10 VISION Bioptics, Inc. | MWP |
| Jul 17, 2009 | K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM Bioptics, Inc. | MWP |
| Nov 21, 2008 | K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM Bioptics, Inc. | MWP |
| Oct 30, 2007 | K072557 | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 Faxitron X-Ray Corp. | MWP |
| Jun 20, 2007 | K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM Kub Technologies, Inc. | MWP |
| Aug 15, 2006 | K061361 | FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 Faxitron X-Ray Corp. | MWP |
| Oct 18, 2005 | K052433 | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM Bioptics, Inc. | MWP |
| Jun 13, 2002 | K021113 | MAMMOPATH Fischer Imaging Corp. | MWP |
| Jul 19, 1985 | K852634 | MICRO-FOCUS 50 CABINET X-RAY Micro-Focus Imaging., Inc. | MWP |
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