FDA applicant

Stereotactic Image Systems, Inc.

Salt Lake City, UT1 decision1991–19910 recalls

FDA records 1 decision for Stereotactic Image Systems, Inc. (Salt Lake City, UT) in 1991: 1 510(k) clearance. All are in product code HAW (Neurological Stereotaxic Instrument). 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, neurology panel, where it files most

How often FDA has decided Stereotactic Image Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stereotactic Image Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stereotactic Image Systems, 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 “Stereotactic”

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

Stereotactic Medical Systems, Inc. 5

Stereotactic Image Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Stereotactic”