GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)— 510(k) K934523

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K934523 for GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1), Substantially Equivalent on 1995-02-08. Applicant: Radionics, Inc..

Clearance details

Applicant: Radionics, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1993-09-17
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.