Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PID-1 PRECISION INTELLIGENT DOSIMETER

K-Number: K954564 · 1996-04-22

ApplicantGammex, Inc.
Decision Date1996-04-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PID-1 PRECISION INTELLIGENT DOSIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Gammex, Inc.. It received FDA 510(k) clearance on 1996-04-22 under 510(k) number K954564. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PID-1 PRECISION INTELLIGENT DOSIMETER?

PID-1 PRECISION INTELLIGENT DOSIMETER is a medical device that received FDA 510(k) clearance on 1996-04-22. The listed applicant is Gammex, Inc.. The 510(k) number is K954564.

When did PID-1 PRECISION INTELLIGENT DOSIMETER receive FDA 510(k) clearance?

PID-1 PRECISION INTELLIGENT DOSIMETER received FDA 510(k) clearance on 1996-04-22, under 510(k) number K954564.

Who is the listed applicant for PID-1 PRECISION INTELLIGENT DOSIMETER?

The FDA 510(k) record lists Gammex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PID-1 PRECISION INTELLIGENT DOSIMETER?

The FDA product code for PID-1 PRECISION INTELLIGENT DOSIMETER is IYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gammex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953514COURIER II

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑