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FDA 510(k)

MICROSELECTRON-HDR (HIGH DOSE RATE)

K-Number: K864210 · 1986-11-26

ApplicantNucletron-Oldelft Corp.
Decision Date1986-11-26
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICROSELECTRON-HDR (HIGH DOSE RATE) is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron-Oldelft Corp.. It received FDA 510(k) clearance on 1986-11-26 under 510(k) number K864210. 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-HDR (HIGH DOSE RATE)?

MICROSELECTRON-HDR (HIGH DOSE RATE) is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Nucletron-Oldelft Corp.. The 510(k) number is K864210.

When did MICROSELECTRON-HDR (HIGH DOSE RATE) receive FDA 510(k) clearance?

MICROSELECTRON-HDR (HIGH DOSE RATE) received FDA 510(k) clearance on 1986-11-26, under 510(k) number K864210.

Who is the listed applicant for MICROSELECTRON-HDR (HIGH DOSE RATE)?

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

What is the FDA product code for MICROSELECTRON-HDR (HIGH DOSE RATE)?

The FDA product code for MICROSELECTRON-HDR (HIGH DOSE RATE) is JAQ.

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Other records listing Nucletron-Oldelft 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.

K953946MICROSELECTRON-HDR VERSION 2K953831N 800 HFK925956MICROSELECTRON - HDR FOR MOBILE ENVIRONMENTK926407MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILMK921991PLATO RADIATION THERAPY PLANNING SYSTEMK915622PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM

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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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