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)

GAMMAMED 12I

K-Number: K891131 · 1989-08-07

ApplicantMick Radio-Nuclear Instruments, Inc.
Decision Date1989-08-07
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMAMED 12I is the device name listed in this FDA 510(k) record. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K891131. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMAMED 12I?

GAMMAMED 12I is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K891131.

When did GAMMAMED 12I receive FDA 510(k) clearance?

GAMMAMED 12I received FDA 510(k) clearance on 1989-08-07, under 510(k) number K891131.

Who is the listed applicant for GAMMAMED 12I?

The FDA 510(k) record lists Mick Radio-Nuclear Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMAMED 12I?

The FDA product code for GAMMAMED 12I is JAQ.

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 Mick Radio-Nuclear Instruments, 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.

K230155Mick Valencia Applicator SetK200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal RetractorK150979CT/MR Compatible M.A.C. Interstitial GYN TemplateK122840CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407K063382HDR CT COMPATIBLE SPLIT RING APPLICATORK063381CT COMPATIBLE F/S/D APPLICATORS

View all 42 devices →

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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.

↑