510(k) Report

FDA applicant

Smv America

Twinsburg, OH7 decisions1997–20011 recall

FDA records 7 decisions for Smv America (Twinsburg, OH) from 1997 to 2001: 7 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Smv America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smv America since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Smv America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Smv America’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission7decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010509Cedars-Sinai BPGS and MocoSmv America · 20014cite it
  • K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 19971cites it
  • K001681Positrace Dual Mode Pet/CT Oncology SystemSmv America · 20001cites it
  • K003358QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect)Smv America · 20011cites it

What has FDA decided for it lately?

  • K010509Cedars-Sinai BPGS and MocoSmv America · 2001
  • K003358QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect)Smv America · 2001
  • K002553DS DS I-SeriesSmv America · 20001 recall
  • K001681Positrace Dual Mode Pet/CT Oncology SystemSmv America · 2000
  • K991565Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and Vision Power Station Computer…Smv America · 1999
  • K972686Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation ComputerSmv America · 1997
  • K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997

All 7 as Smv America →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002553SMV DSI, System, Tomography, Computed, EmissionDec 10, 2025Class II