510(k) Report

FDA applicant

Sigma Vision, Inc.

Rockville, MD1 decision2003–20030 recalls

FDA records 1 decision for Sigma Vision, Inc. (Rockville, MD) in 2003: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 3 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 Sigma Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sigma Vision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sigma Vision, Inc. 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?

  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K030544RFX Fluroscopic Digital Imaging SystemSigma Vision, Inc. · 2003

The one decision as Sigma Vision, Inc. →

Other applicant names beginning “Sigma”

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

Sigma Chemical Co. 231Sigma Diagnostics, Inc. 164Sigma Medical, Inc. 13Sigma 6Sigma Medical Supplies Corp. 5Sigma Intl. 3Sigma Cell Culture Reagents 2Sigma Scientific Services, LLC 1Sigma Teleproducts, Inc. 1Sigma Biomedics, Inc. 1Sigma Intl. General Medical Apparatus, Inc. 1Sigma-Brillen 1