# Smart Soft Healthcare AD

- Location (FDA's records): Varna, BG
- FDA decisions: 3 (2022–2026): 3 510(k) clearances
- Product codes: QIH (3)
- 510(k) review time since 2016: median 107 days, against 134 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (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
- Smart Soft Healthcare: 2 (https://510kreport.com/company/smart-soft-healthcare)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Smart Soft Healthcare: 1 (https://510kreport.com/company/smart-soft-healthcare)
- Mskai: 1 (https://510kreport.com/company/mskai)
- Scandiags AG: 1 (https://510kreport.com/company/scandiags)
- Remedy Logic, Inc.: 1 (https://510kreport.com/company/remedy-logic)

## Its most-cited devices
- K220497: CoLumbo (2022), cited by 4

## Recent decisions
- K254015: CoLumbo C-Spine (Apr 1, 2026)
- K250367: CoLumboX (May 28, 2025)
- K220497: CoLumbo (Jun 23, 2022)

Source page: https://510kreport.com/company/smart-soft-healthcare-ad