# Prognosys Medical Systems Private Limited

- Location (FDA's records): Bangalore, IN
- FDA decisions: 3 (2019–2025): 3 510(k) clearances
- Product codes: MQB (1), KPR (1), IZL (1)
- 510(k) review time since 2016: median 236 days, against 153 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 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
- Innocare Optoelectronics Corp.: 3 (https://510kreport.com/company/innocare-optoelectronics)
- Sg Healthcare Co, Ltd.: 1 (https://510kreport.com/company/sg-healthcare)
- Summit Industries, Inc.: 1 (https://510kreport.com/company/summit-industries)
- Remedi Co., Ltd.: 1 (https://510kreport.com/company/remedi)

## Recent decisions
- K243473: Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus (Jul 29, 2025)
- K240771: PRORAD X-Ray Flat Panel Detector with DROC (Nov 12, 2024)
- K183541: ProRad 2FC and ProRad 3NC Stationary Radiographic Systems (Jan 24, 2019)

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