Flat Panel Detector
510(k) K201591
Flat Panel Detector is a medical device (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by KA Imaging Inc, cleared under FDA 510(k) K201591 on 3 Sep 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201591 | Date3 Sep 2020 | StatusActive |
Official records
- FDA 510(k) database K201591
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- FDA applicant
- Ka Imaging, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201591
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Reveal 35C 1 | 101 / 1 | 16280119411015 | — | No longer on the market |
| Reveal 35C 1 | 101 / 1 | 00628011941015 | — | On the market |
Similar devices
Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).
- CDR - PAN MODEL 4700 by Schick Technologies, Inc.
- DIGITAL RADIOGRAPHY by Canon Inc. -Medical Equipment Group
- MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM by EASTMAN KODAK COMPANY
- FDR ES C35 DR-ID 1273 SE E by FUJIFILM CORPORATION
- Nexus DR Digital X-ray Imaging System by Varex Imaging Corporation
- Li-Polymer Battery Pack DR1280 SE BATTERY E by FUJIFILM CORPORATION
- FDR D-EVO II FLAT PANEL DETECTOR SYSTEM by Fujifilm Medical System U.S.A., Inc.
- PEDRA 17FC PEDRA-17FC by Radisen Co., Ltd.
- Wireless Digital Flat Panel Detector by Iray Technology Taicang, Ltd.
- 1417WCE-GF by Rayence Co., Ltd.