# Sopha Medical Systems, Inc.

- Location (FDA's records): Columbia, MD
- FDA decisions: 8 (1987–1996): 8 510(k) clearances
- Product codes: KPS (4), IYX (3), IXY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Segami Corporation: 1 (https://510kreport.com/company/segami)
- Smv America: 1 (https://510kreport.com/company/smv-america)

## Its most-cited devices
- K952190: Transmission Attenuation Correction (Tac) Package (1996), cited by 1
- K913641: Sophy NXT (1991), cited by 1

## Recent decisions
- K952190: Transmission Attenuation Correction (Tac) Package (Jan 18, 1996)
- K942837: DST-XL (Jan 5, 1995)
- K921008: Vector Series (Apr 27, 1992)
- K913641: Sophy NXT (Dec 17, 1991)
- K911346: Sophycamera DSX Bodytrak (Apr 18, 1991)
- K894931: Sophycamera DSX Rectangular (Oct 27, 1989)
- K872132: Sophy Series of Nuclear Medicine Computer Systems (Oct 26, 1987)
- K872297: DS-7 Nuclear Medicine Gamma Camera (Aug 12, 1987)

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