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FDA 510(k)

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY

K-Number: K121448 · 2012-07-02

ApplicantElekta Inc. D/B/A Nucletron Corporation
Decision Date2012-07-02
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Inc. D/B/A Nucletron Corporation. It received FDA 510(k) clearance on 2012-07-02 under 510(k) number K121448. 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 ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY?

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY is a medical device that received FDA 510(k) clearance on 2012-07-02. The listed applicant is Elekta Inc. D/B/A Nucletron Corporation. The 510(k) number is K121448.

When did ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY receive FDA 510(k) clearance?

ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY received FDA 510(k) clearance on 2012-07-02, under 510(k) number K121448.

Who is the listed applicant for ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY?

The FDA 510(k) record lists Elekta Inc. D/B/A Nucletron Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY?

The FDA product code for ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY is MUJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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