FDA 510(k)

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

K-Number: K111791 · 2011-09-23

ApplicantGamma Medica-Ideas Incorporated

Decision Date2011-09-23

Product CodeIYX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Medica-Ideas Incorporated. It received FDA 510(k) clearance on 2011-09-23 under 510(k) number K111791. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMAGEM MOLECULAR BREAST IMAGING SYSTEM?

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-23. The listed applicant is Gamma Medica-Ideas Incorporated. The 510(k) number is K111791.

When did LUMAGEM MOLECULAR BREAST IMAGING SYSTEM receive FDA 510(k) clearance?

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM received FDA 510(k) clearance on 2011-09-23, under 510(k) number K111791.

Who is the listed applicant for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM?

The FDA 510(k) record lists Gamma Medica-Ideas Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM?

The FDA product code for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM is IYX.

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Other records listing Gamma Medica-Ideas Incorporated as applicant

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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.