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FDA 510(k)

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

K-Number: K072445 · 2007-09-14

ApplicantNucletron Corp.
Decision Date2007-09-14
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K072445. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRATED BRACHYTHERAPY UNIT - DIGITAL?

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Nucletron Corp.. The 510(k) number is K072445.

When did INTEGRATED BRACHYTHERAPY UNIT - DIGITAL receive FDA 510(k) clearance?

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL received FDA 510(k) clearance on 2007-09-14, under 510(k) number K072445.

Who is the listed applicant for INTEGRATED BRACHYTHERAPY UNIT - DIGITAL?

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 INTEGRATED BRACHYTHERAPY UNIT - DIGITAL?

The FDA product code for INTEGRATED BRACHYTHERAPY UNIT - DIGITAL is KPQ.

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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 CATHETERSK041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001K041933MICROSELECTRON PDRK041719ONCENTRA-VISIRK031349OTP 1.2

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Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK061006IKOENGELOIkoetech, LLCK052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNucletron Corporation

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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