# Allengers Medical Systems Limited

- Location (FDA's records): Derabassi, Distt Mohali, IN
- FDA decisions: 8 (2017–2026): 8 510(k) clearances
- Product codes: KPR (3), OWB (2), MQB (2), OXO (1)
- 510(k) review time since 2016: median 90 days, against 53 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 23 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 5 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Innocare Optoelectronics Corp.: 3 (https://510kreport.com/company/innocare-optoelectronics)
- Ziehm Imaging GmbH: 2 (https://510kreport.com/company/ziehm-imaging)
- Perkinelmer, Inc.: 2 (https://510kreport.com/company/perkinelmer)
- Ge Oec Medical Systems, Inc.: 1 (https://510kreport.com/company/ge-oec-medical-systems)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Varian Medical Systems, X-Ray Products-Infimed: 1 (https://510kreport.com/company/varian-medical-systems-x-ray-products-infimed)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)

## Firms that cite its devices most
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)

## Its most-cited devices
- K200218: Digiscan FDX (2020), cited by 1
- K223060: DigiX FDX (2022), cited by 1
- K223009: Wireless/Wired X-Ray Flat Panel Detectors (2022), cited by 1
- K192541: DigiX FDX (2019), cited by 1
- K162529: DigiX FDX (2017), cited by 1

## Recent decisions
- K253296: Digital C-ARM with 3D (Jun 5, 2026)
- K243734: Wireless/ Wired X-Ray Flat Panel Detectors (Apr 18, 2025)
- K223009: Wireless/Wired X-Ray Flat Panel Detectors (Nov 27, 2022)
- K223060: DigiX FDX (Oct 26, 2022)
- K220311: Cardiovascular Angiography System (May 3, 2022)
- K200218: Digiscan FDX (Jul 13, 2020)
- K192541: DigiX FDX (Oct 16, 2019)
- K162529: DigiX FDX (Mar 3, 2017)

Source page: https://510kreport.com/company/allengers-medical-systems