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FDA 510(k)

MOLECULAR BREAST IMAGING SOFTWARE

K-Number: K111731 · 2011-09-15

ApplicantGamma Medica-Ideas Incorporated
Decision Date2011-09-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOLECULAR BREAST IMAGING SOFTWARE 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 2011-09-15 under 510(k) number K111731. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLECULAR BREAST IMAGING SOFTWARE?

MOLECULAR BREAST IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Gamma Medica-Ideas Incorporated. The 510(k) number is K111731.

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

MOLECULAR BREAST IMAGING SOFTWARE received FDA 510(k) clearance on 2011-09-15, under 510(k) number K111731.

Who is the listed applicant for MOLECULAR BREAST IMAGING SOFTWARE?

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 MOLECULAR BREAST IMAGING SOFTWARE?

The FDA product code for MOLECULAR BREAST IMAGING SOFTWARE is LLZ.

Related Clinical Trials

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.

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Other records listing Gamma Medica-Ideas Incorporated 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.

K111791LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

Related Devices (Code: LLZ)

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.

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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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