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)

CURIETRON 192 LOW DOSE RATE

K-Number: K881323 · 1989-01-17

ApplicantCompagnie Oris Industrie, S.A.
Decision Date1989-01-17
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURIETRON 192 LOW DOSE RATE is the device name listed in this FDA 510(k) record. The listed applicant is Compagnie Oris Industrie, S.A.. It received FDA 510(k) clearance on 1989-01-17 under 510(k) number K881323. 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 CURIETRON 192 LOW DOSE RATE?

CURIETRON 192 LOW DOSE RATE is a medical device that received FDA 510(k) clearance on 1989-01-17. The listed applicant is Compagnie Oris Industrie, S.A.. The 510(k) number is K881323.

When did CURIETRON 192 LOW DOSE RATE receive FDA 510(k) clearance?

CURIETRON 192 LOW DOSE RATE received FDA 510(k) clearance on 1989-01-17, under 510(k) number K881323.

Who is the listed applicant for CURIETRON 192 LOW DOSE RATE?

The FDA 510(k) record lists Compagnie Oris Industrie, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURIETRON 192 LOW DOSE RATE?

The FDA product code for CURIETRON 192 LOW DOSE RATE 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 Compagnie Oris Industrie, S.A. 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.

K860311ACTHK-PR RIA KIT

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.

↑