510(k) Report

FDA applicant

Surgi-Vision, Inc.

Columbia, MD9 decisions1999–20110 recalls

FDA records 9 decisions for Surgi-Vision, Inc. (Columbia, MD) from 1999 to 2011: 9 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and ORR (Neurological Stereotaxic Instrument, Real-Time…). Its devices cite 11 predicates, 8 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 Surgi-Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Surgi-Vision”

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