510(k) Report

FDA applicant

Biospace Med

Washington, DC4 decisions2007–20111 recall

FDA records 4 decisions for Biospace Med (Washington, DC) from 2007 to 2011: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPR (System, X-Ray, Stationary). Its devices cite 13 predicates, 3 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 Biospace Med’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12008: 12010: 12011: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biospace Med’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?

  • LLZSystem, Image Processing, Radiological3decisions
  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K080529Stereos WorkstationBiospace Med · 20084cite it
  • K090050Stereos WorkstationBiospace Med · 20103cite it
  • K071546EOSBiospace Med · 20072cite it
  • K101398Stereos WorkstationBiospace Med · 20112cite it

What has FDA decided for it lately?

  • K101398Stereos WorkstationBiospace Med · 20111 recall
  • K090050Stereos WorkstationBiospace Med · 2010
  • K080529Stereos WorkstationBiospace Med · 2008
  • K071546EOSBiospace Med · 20071 recall

All 4 as Biospace Med →

What has been recalled?

1 recall linked to its devices; the latest:

  • K071546Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10…Apr 13, 2011

Other applicant names beginning “Biospace”

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

Biospace Corporation Limited 10