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FDA 510(k)

OTP 1.2

K-Number: K031349 · 2003-08-07

ApplicantNucletron Corp.
Decision Date2003-08-07
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OTP 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2003-08-07 under 510(k) number K031349. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTP 1.2?

OTP 1.2 is a medical device that received FDA 510(k) clearance on 2003-08-07. The listed applicant is Nucletron Corp.. The 510(k) number is K031349.

When did OTP 1.2 receive FDA 510(k) clearance?

OTP 1.2 received FDA 510(k) clearance on 2003-08-07, under 510(k) number K031349.

Who is the listed applicant for OTP 1.2?

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 OTP 1.2?

The FDA product code for OTP 1.2 is MUJ.

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: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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