PID-1 PRECISION INTELLIGENT DOSIMETER— 510(k) K954564

Name: FDA 510(k) clearance K954564
Creator: U.S. Food and Drug Administration
Published: 1996-04-22

Substantially Equivalent

Gammex, Inc.

FDA 510(k) clearance K954564 for PID-1 PRECISION INTELLIGENT DOSIMETER, Substantially Equivalent on 1996-04-22. Applicant: Gammex, Inc.. Device class: 2.

Clearance details

Applicant: Gammex, Inc.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1995-10-02
Decision date: 1996-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12
K253004 — LUNA 3D2026-06-04

More clearances from Gammex, Inc.

view all

K152303 — CT Sim Laser System2015-09-11
K953514 — COURIER II1995-10-07

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.