REGIUS Cassette A2RS
REGIUS Cassette A2RS is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K092717 on 30 Oct 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141928350), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04560141928350 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092717 | Date30 Oct 2009 | StatusActive |
Official records
- AccessGUDID record 04560141928350
- FDA 510(k) database K092717
Across registries
- FDA 510(k) K092717 decided 30 Oct 2009 Active
- FDA GUDID UDI-DI 04560141928350 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092717
- Listed FDA GUDID 04560141928350
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- REGIUS Cassette
- Generic name
- Digital imaging cassette
- Model / reference
- A2RS
- Primary DI / UDI-DI
- 04560141928350
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Digital imaging cassette
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).
- DIGITAL RADIOGRAPHY CXDI-40G COMPACT by Canon USA, Inc.
- Dicompacs DX-R With Flat Panel by OEHM UND REHBEIN GMBH
- KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM by Medicatech USA
- Nexus DR Digital X-Ray Imaging System (with vSharp) by Varex Imaging Corporation
- DIGITAL RADIOGRAPHY by Canon Inc. -Medical Equipment Group
- AEROPILOT by Konica Minolta Medical & Graphic, Inc.
- CareView 750Cw/750C X-ray Flat Panel Detectors by Careray Digital Medical System Co., Ltd.
- Focus 35C Detector, Trimax 35C Detector by Iray Technology Taicang, Ltd.
- Vivix-S with VXVue by VIEWORKS CO., LTD.
- PHILIPS ESSENTA DR by Philips Medical Systems GmbH, Dmc