510(k) Report

FDA applicant

Breakaway Imaging, LLC

Littleton, MA2 decisions2005–20064 recalls

FDA records 2 decisions for Breakaway Imaging, LLC (Littleton, MA) from 2005 to 2006: 2 510(k) clearances. All are in product code OXO (Image-Intensified Fluoroscopic X-Ray System…). Its devices cite 3 predicates, 1 of them its own earlier devices. 4 recalls are 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 Breakaway Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Breakaway Imaging, LLC since 2007.

Recalls per year

1in 2010

2007: 22008: 12010: 1
2007high 2 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Breakaway Imaging, LLC 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?

  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K050996O-Arm Imaging SystemBreakaway Imaging, LLC · 20053cite it
  • K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 20062cite it

What has FDA decided for it lately?

  • K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 20061 recall
  • K050996O-Arm Imaging SystemBreakaway Imaging, LLC · 20054 recalls

All 2 as Breakaway Imaging, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K050996O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for…May 10, 2010
  • K050996BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images…Jun 30, 2008
  • K050996Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027Nov 27, 2007
  • K050996Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic…Oct 17, 2007