510(k) Report

FDA applicant

Orison Corporation

Johnson City, TN2 decisions2007–20070 recalls

FDA records 2 decisions for Orison Corporation (Johnson City, TN) in 2007: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and MUI (Media, Coupling, Ultrasound). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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 Orison Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • MUIMedia, Coupling, Ultrasound1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K072515Embrace GelOrison Corporation · 20072cite it
  • K070477Orison Embrace SystemOrison Corporation · 20071cites it

What has FDA decided for it lately?

  • K072515Embrace GelOrison Corporation · 2007
  • K070477Orison Embrace SystemOrison Corporation · 2007

All 2 as Orison Corporation →