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FDA 510(k)

HDR IORT SHIELDED APPLICATOR

K-Number: K052351 · 2005-10-17

ApplicantMick Radio-Nuclear Instruments, Inc.
Decision Date2005-10-17
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDR IORT SHIELDED 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 2005-10-17 under 510(k) number K052351. 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 IORT SHIELDED APPLICATOR?

HDR IORT SHIELDED APPLICATOR is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K052351.

When did HDR IORT SHIELDED APPLICATOR receive FDA 510(k) clearance?

HDR IORT SHIELDED APPLICATOR received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052351.

Who is the listed applicant for HDR IORT SHIELDED 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 IORT SHIELDED APPLICATOR?

The FDA product code for HDR IORT SHIELDED 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 0407K063382HDR CT COMPATIBLE SPLIT RING APPLICATORK063381CT COMPATIBLE F/S/D APPLICATORS

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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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