# Osko, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 6 (2015–2020): 6 510(k) clearances
- Product codes: MQB (3), KPR (2), LLZ (1)
- 510(k) review time since 2016: median 30 days, against 30 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 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
- Rayence Co., Ltd.: 2 (https://510kreport.com/company/rayence)
- Cedara Software Corp.: 1 (https://510kreport.com/company/cedara-software)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)
- Canon, Inc.: 1 (https://510kreport.com/company/canon)
- Siemens Medical Solution: 1 (https://510kreport.com/company/siemens-medical-solution)

## Its most-cited devices
- K172681: Edge Air Digital Flat Panel X-ray Detector (2017), cited by 1

## Recent decisions
- K201503: Edge Air (1417) Digital Flat Panel X-ray Detector (Jun 29, 2020)
- K172681: Edge Air Digital Flat Panel X-ray Detector (Oct 6, 2017)
- K172682: Edge Digital Flat Panel X-ray Detector (Oct 6, 2017)
- K163048: Smart Stitching Software System, Image Processing, Radiological (Jul 28, 2017)
- K150663: Diagnostic X-ray System (May 7, 2015)
- K150506: ELIAN Digital Diagnostic X-ray System (Apr 8, 2015)

Source page: https://510kreport.com/company/osko