510(k) Report

FDA applicant

Orbital Therapy, LLC

Winchester, MA1 decision2009–20091 recall

FDA records 1 decision for Orbital Therapy, LLC (Winchester, MA) in 2009: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 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 Orbital Therapy, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Orbital Therapy, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K090349Clearvue Prone Breast Treatment TableOrbital Therapy, LLC · 20091cites it

What has FDA decided for it lately?

  • K090349Clearvue Prone Breast Treatment TableOrbital Therapy, LLC · 20091 recall

The one decision as Orbital Therapy, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090349Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device…Jan 7, 2016Class II

Other applicant names beginning “Orbital”

FDA records each applicant name separately; these may or may not be the same firm.

Orbital Research, Inc. 1