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FDA 510(k)

MICROSELECTRON PDR

K-Number: K041933 · 2004-08-18

ApplicantNucletron Corp.
Decision Date2004-08-18
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICROSELECTRON PDR is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2004-08-18 under 510(k) number K041933. 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 MICROSELECTRON PDR?

MICROSELECTRON PDR is a medical device that received FDA 510(k) clearance on 2004-08-18. The listed applicant is Nucletron Corp.. The 510(k) number is K041933.

When did MICROSELECTRON PDR receive FDA 510(k) clearance?

MICROSELECTRON PDR received FDA 510(k) clearance on 2004-08-18, under 510(k) number K041933.

Who is the listed applicant for MICROSELECTRON PDR?

The FDA 510(k) record lists Nucletron Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSELECTRON PDR?

The FDA product code for MICROSELECTRON PDR is JAQ.

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Other records listing Nucletron Corp. 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.

K092804MICROSELECTRON HDR V2, MODEL 105.999K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALK041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001K041719ONCENTRA-VISIRK031349OTP 1.2

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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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