FDA Product Code
FDA Product Code MWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 | Traditional | PDF ↗ |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 | Traditional | PDF ↗ |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021-09-20 | Special | PDF ↗ |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021-08-31 | Special | PDF ↗ |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021-08-31 | Special | PDF ↗ |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 | Traditional | PDF ↗ |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020-06-12 | Traditional | PDF ↗ |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019-12-27 | Traditional | PDF ↗ |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | 2019-12-13 | Traditional | PDF ↗ |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019-06-20 | Traditional | PDF ↗ |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019-03-14 | Traditional | PDF ↗ |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019-01-10 | Traditional | PDF ↗ |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018-05-09 | Traditional | PDF ↗ |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017-07-18 | Traditional | PDF ↗ |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016-04-01 | Special | PDF ↗ |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | 2012-09-25 | Traditional | PDF ↗ |
| K111508 | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | Hologic, Inc. | 2011-08-19 | Traditional | PDF ↗ |
| K091928 | 10 X 10 VISION | Bioptics, Inc. | 2010-06-16 | Traditional | PDF ↗ |
| K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | 2009-07-17 | Traditional | PDF ↗ |
| K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2008-11-21 | Traditional | PDF ↗ |
| K072557 | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 | Faxitron X-Ray Corp. | 2007-10-30 | Traditional | PDF ↗ |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Kub Technologies, Inc. | 2007-06-20 | Traditional | PDF ↗ |
| K061361 | FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 | Faxitron X-Ray Corp. | 2006-08-15 | Traditional | PDF ↗ |
| K052433 | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2005-10-18 | Traditional | PDF ↗ |
| K021113 | MAMMOPATH | Fischer Imaging Corp. | 2002-06-13 | Traditional | PDF ↗ |
| K852634 | MICRO-FOCUS 50 CABINET X-RAY | Micro-Focus Imaging., Inc. | 1985-07-19 | Traditional | PDF ↗ |
Product code MWP · Class II · Radiology. Data: openFDA.