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FDA 510(k)

HDR CT COMPATIBLE SPLIT RING APPLICATOR

K-Number: K063382 · 2006-12-26

ApplicantMick Radio-Nuclear Instruments, Inc.
Decision Date2006-12-26
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDR CT COMPATIBLE SPLIT RING APPLICATOR 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 2006-12-26 under 510(k) number K063382. 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 HDR CT COMPATIBLE SPLIT RING APPLICATOR?

HDR CT COMPATIBLE SPLIT RING APPLICATOR is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K063382.

When did HDR CT COMPATIBLE SPLIT RING APPLICATOR receive FDA 510(k) clearance?

HDR CT COMPATIBLE SPLIT RING APPLICATOR received FDA 510(k) clearance on 2006-12-26, under 510(k) number K063382.

Who is the listed applicant for HDR CT COMPATIBLE SPLIT RING APPLICATOR?

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 HDR CT COMPATIBLE SPLIT RING APPLICATOR?

The FDA product code for HDR CT COMPATIBLE SPLIT RING APPLICATOR is JAQ.

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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 0407K063381CT COMPATIBLE F/S/D APPLICATORSK052351HDR IORT SHIELDED APPLICATOR

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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.

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