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FDA 510(k)

IBU, INTEGRATED BRACHY THERAPY UNIT

K-Number: K973848 · 1998-01-22

ApplicantNucletron Corp.
Decision Date1998-01-22
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBU, INTEGRATED BRACHY THERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 1998-01-22 under 510(k) number K973848. 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 IBU, INTEGRATED BRACHY THERAPY UNIT?

IBU, INTEGRATED BRACHY THERAPY UNIT is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Nucletron Corp.. The 510(k) number is K973848.

When did IBU, INTEGRATED BRACHY THERAPY UNIT receive FDA 510(k) clearance?

IBU, INTEGRATED BRACHY THERAPY UNIT received FDA 510(k) clearance on 1998-01-22, under 510(k) number K973848.

Who is the listed applicant for IBU, INTEGRATED BRACHY THERAPY UNIT?

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 IBU, INTEGRATED BRACHY THERAPY UNIT?

The FDA product code for IBU, INTEGRATED BRACHY THERAPY UNIT 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 CATHETERSK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALK041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001K041933MICROSELECTRON PDRK041719ONCENTRA-VISIR

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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, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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