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FDA 510(k)

IR-192 IMPLANT

K-Number: K844248 · 1985-04-10

ApplicantRads S.L., Inc.
Decision Date1985-04-10
Product CodeIWA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IR-192 IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Rads S.L., Inc.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K844248. The device is classified under product code IWA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IR-192 IMPLANT?

IR-192 IMPLANT is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Rads S.L., Inc.. The 510(k) number is K844248.

When did IR-192 IMPLANT receive FDA 510(k) clearance?

IR-192 IMPLANT received FDA 510(k) clearance on 1985-04-10, under 510(k) number K844248.

Who is the listed applicant for IR-192 IMPLANT?

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

What is the FDA product code for IR-192 IMPLANT?

The FDA product code for IR-192 IMPLANT is IWA.

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 Rads S.L., 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.

K903465IR-192 IMPLANTK874895IR-192 IMPLANT

Related Devices (Code: IWA)

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.

K915253IR-192 IMPLANT, MODIFICATIONOmnitron Intl., Inc.K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.K874895IR-192 IMPLANTRads S.L., Inc.K850382IRIDIUM SEEDSRadiation Safety & Nuclear Products, Inc.K850726WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.K850163IRIDIUM 192 WIRESSyncor Intl. Corp.

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.

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