# Smv America

- Location (FDA's records): Twinsburg, OH
- FDA decisions: 7 (1997–2001): 7 510(k) clearances
- Product codes: KPS (7)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Adac Laboratories: 3 (https://510kreport.com/company/adac-laboratories)
- Ugm Medical Systems, Inc.: 2 (https://510kreport.com/company/ugm-medical-systems)
- Sopha Medical Systems, Inc.: 1 (https://510kreport.com/company/sopha-medical-systems)

## Firms that cite its devices most
- Digirad Corp.: 4 (https://510kreport.com/company/digirad)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Cedars-Sinai Medical Center: 1 (https://510kreport.com/company/cedars-sinai-medical-center)

## Its most-cited devices
- K010509: Cedars-Sinai BPGS and Moco (2001), cited by 4
- K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station (1997), cited by 1
- K001681: Positrace Dual Mode Pet/CT Oncology System (2000), cited by 1
- K003358: QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect) (2001), cited by 1

## Recent decisions
- K010509: Cedars-Sinai BPGS and Moco (Apr 27, 2001)
- K003358: QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect) (Jan 19, 2001)
- K002553: DS DS I-Series (Sep 15, 2000)
- K001681: Positrace Dual Mode Pet/CT Oncology System (Aug 25, 2000)
- K991565: Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and Vision Power Station Computer, for Use in S (Aug 2, 1999)
- K972686: Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer (Oct 14, 1997)
- K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station (Mar 11, 1997)

Source page: https://510kreport.com/company/smv-america