MWP — Cabinet, X-Ray System Class II
FDA product code MWP covers "Cabinet, X-Ray System", a Class II medical device regulated under 21 CFR 892.1680. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MWP
- Device Class
- Class II
- Regulation Number
- 892.1680
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230140 | compai healthcare (suzhou) co | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U | April 24, 2023 |
| K230136 | compai healthcare (suzhou) co | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | April 24, 2023 |
| K213691 | cirdan imaging | Solas OR | December 22, 2021 |
| K210955 | kub technologies | Kubtec Mozart Supra (XPERT 84) Radiography System | September 20, 2021 |
| K210957 | kub technologies | Kubec Xpert 80 Radiography System | August 31, 2021 |
| K210956 | kub technologies | Kubtec Mozart (XPERT42) | August 31, 2021 |
| K202713 | compai healthcare (shenzhen) co | TrueView 100 Pro | November 18, 2020 |
| K200756 | kub technologies | Kubtec Mozart Supra | June 12, 2020 |
| K192939 | clarix imaging | Volumetric Specimen Imager | December 27, 2019 |
| K193317 | cirdan imaging limited | CoreLite X-Ray Specimen Cabinet | December 13, 2019 |
| K183624 | kub technologies | Kubtec Mozart (Xpert42) | June 20, 2019 |
| K183142 | faxitron bioptics | PathVisionXL | March 14, 2019 |
| K182727 | hologic | Trident HD Specimen Radiography System | January 10, 2019 |
| K173309 | faxitron bioptics | Faxitron VisionCT | May 9, 2018 |
| K170786 | faxitron bioptics | Faxitron Bioptics Speciemen Radiography System | July 18, 2017 |
| K153583 | faxitron bioptics | BioVision Plus | April 1, 2016 |
| K122428 | faxitron bioptics | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | September 25, 2012 |
| K111508 | hologic | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | August 19, 2011 |
| K091928 | bioptics | 10 X 10 VISION | June 16, 2010 |
| K091558 | bioptics | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | July 17, 2009 |