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FDA 510(k)

LEKSELL GAMMAPLAN 4C WITH MULTIVIEW

K-Number: K042269 · 2004-09-08

ApplicantElekta Instrument AB
Decision Date2004-09-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LEKSELL GAMMAPLAN 4C WITH MULTIVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K042269. 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 LEKSELL GAMMAPLAN 4C WITH MULTIVIEW?

LEKSELL GAMMAPLAN 4C WITH MULTIVIEW is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Elekta Instrument AB. The 510(k) number is K042269.

When did LEKSELL GAMMAPLAN 4C WITH MULTIVIEW receive FDA 510(k) clearance?

LEKSELL GAMMAPLAN 4C WITH MULTIVIEW received FDA 510(k) clearance on 2004-09-08, under 510(k) number K042269.

Who is the listed applicant for LEKSELL GAMMAPLAN 4C WITH MULTIVIEW?

The FDA 510(k) record lists Elekta Instrument AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEKSELL GAMMAPLAN 4C WITH MULTIVIEW?

The FDA product code for LEKSELL GAMMAPLAN 4C WITH MULTIVIEW is MUJ.

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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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