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FDA 510(k)

CT/MR Compatible M.A.C. Interstitial GYN Template

K-Number: K150979 · 2016-05-31

ApplicantMick Radio-Nuclear Instruments, Inc.
Decision Date2016-05-31
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT/MR Compatible M.A.C. Interstitial GYN Template 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 2016-05-31 under 510(k) number K150979. 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 CT/MR Compatible M.A.C. Interstitial GYN Template?

CT/MR Compatible M.A.C. Interstitial GYN Template is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K150979.

When did CT/MR Compatible M.A.C. Interstitial GYN Template receive FDA 510(k) clearance?

CT/MR Compatible M.A.C. Interstitial GYN Template received FDA 510(k) clearance on 2016-05-31, under 510(k) number K150979.

Who is the listed applicant for CT/MR Compatible M.A.C. Interstitial GYN Template?

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 CT/MR Compatible M.A.C. Interstitial GYN Template?

The FDA product code for CT/MR Compatible M.A.C. Interstitial GYN Template is JAQ.

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 Retractor

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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