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FDA 510(k)

CLEARVUE PRONE BREAST TREATMENT TABLE

K-Number: K090349 · 2009-03-09

ApplicantOrbital Therapy, LLC
Decision Date2009-03-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLEARVUE PRONE BREAST TREATMENT TABLE is the device name listed in this FDA 510(k) record. The listed applicant is Orbital Therapy, LLC. It received FDA 510(k) clearance on 2009-03-09 under 510(k) number K090349. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARVUE PRONE BREAST TREATMENT TABLE?

CLEARVUE PRONE BREAST TREATMENT TABLE is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Orbital Therapy, LLC. The 510(k) number is K090349.

When did CLEARVUE PRONE BREAST TREATMENT TABLE receive FDA 510(k) clearance?

CLEARVUE PRONE BREAST TREATMENT TABLE received FDA 510(k) clearance on 2009-03-09, under 510(k) number K090349.

Who is the listed applicant for CLEARVUE PRONE BREAST TREATMENT TABLE?

The FDA 510(k) record lists Orbital Therapy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARVUE PRONE BREAST TREATMENT TABLE?

The FDA product code for CLEARVUE PRONE BREAST TREATMENT TABLE is IYE.

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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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