MWP · Cabinet, X-Ray System
Radiology · 21 CFR 892.1680 · Class 2
Overview
| Product Code | MWP |
|---|---|
| Device Name | Cabinet, X-Ray System |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | Apr 24, 2023 | SESE |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | Apr 24, 2023 | SESE |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | Dec 22, 2021 | SESE |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | Sep 20, 2021 | SESE |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | Aug 31, 2021 | SESE |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | Aug 31, 2021 | SESE |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | Nov 18, 2020 | SESE |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | Jun 12, 2020 | SESE |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | Dec 27, 2019 | SESE |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | Dec 13, 2019 | SESE |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | Jun 20, 2019 | SESE |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | Mar 14, 2019 | SESE |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | Jan 10, 2019 | SESE |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | May 9, 2018 | SESE |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | Jul 18, 2017 | SESE |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | Apr 1, 2016 | SESE |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | Sep 25, 2012 | SESE |
| K111508 | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | Hologic, Inc. | Aug 19, 2011 | SESE |
| K091928 | 10 X 10 VISION | Bioptics, Inc. | Jun 16, 2010 | SESE |
| K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | Jul 17, 2009 | SESE |
Top Applicants
- Kub Technologies, Inc. — 6 clearances
- Faxitron Bioptics, LLC — 5 clearances
- Bioptics, Inc. — 4 clearances
- Compai Healthcare (Suzhou) Co.,Ltd — 2 clearances
- Faxitron X-Ray Corp. — 2 clearances
