FDA 510(k) Applications for Medical Device Product Code "MWP"
(Cabinet,X-Ray System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K091928 | BIOPTICS, INC. | 10 X 10 VISION | 06/16/2010 |
| K091558 | BIOPTICS, INC. | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | 07/17/2009 |
| K082432 | BIOPTICS, INC. | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | 11/21/2008 |
| K052433 | BIOPTICS, INC. | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | 10/18/2005 |
| K193317 | Cirdan Imaging Limited | CoreLite X-Ray Specimen Cabinet | 12/13/2019 |
| K213691 | Cirdan Imaging Ltd | Solas OR | 12/22/2021 |
| K192939 | Clarix Imaging | Volumetric Specimen Imager | 12/27/2019 |
| K202713 | CompAI Healthcare (Shenzhen) Co.,ltd | TrueView 100 Pro | 11/18/2020 |
| K230136 | CompAI Healthcare (Suzhou) Co.,ltd | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | 04/24/2023 |
| K230140 | CompAI Healthcare (Suzhou) Co.,ltd | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | 04/24/2023 |
| K153583 | FAXITRON BIOPTICS LLC | BioVision Plus | 04/01/2016 |
| K170786 | Faxitron Bioptics LLC | Faxitron Bioptics Speciemen Radiography System | 07/18/2017 |
| K122428 | FAXITRON BIOPTICS LLC | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | 09/25/2012 |
| K173309 | Faxitron Bioptics Llc | Faxitron VisionCT | 05/09/2018 |
| K183142 | Faxitron Bioptics LLC | PathVisionXL | 03/14/2019 |
| K061361 | FAXITRON X-RAY CORP. | FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 | 08/15/2006 |
| K072557 | FAXITRON X-RAY CORP. | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 | 10/30/2007 |
| K021113 | FISCHER IMAGING CORP. | MAMMOPATH | 06/13/2002 |
| K182727 | Hologic, Inc. | Trident HD Specimen Radiography System | 01/10/2019 |
| K111508 | HOLOGIC, INC. | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | 08/19/2011 |
| K071233 | KUB TECHNOLOGIES, INC | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | 06/20/2007 |
| K210957 | KUB Technologies, Inc. | Kubec Xpert 80 Radiography System | 08/31/2021 |
| K183624 | KUB Technologies, Inc. | Kubtec Mozart (Xpert42) | 06/20/2019 |
| K210956 | KUB Technologies, Inc. | Kubtec Mozart (XPERT42) | 08/31/2021 |
| K200756 | KUB Technologies, Inc. | Kubtec Mozart Supra | 06/12/2020 |
| K210955 | KUB Technologies, Inc. | Kubtec Mozart Supra (XPERT 84) Radiography System | 09/20/2021 |
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