FDA 510(k)

MAMMI

K-Number: K161631 · 2016-07-28

ApplicantGeneral Equipment For Medical Imaging

Decision Date2016-07-28

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MAMMI is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161631. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMI?

MAMMI is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is General Equipment For Medical Imaging. The 510(k) number is K161631.

When did MAMMI receive FDA 510(k) clearance?

MAMMI received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161631.

Who is the listed applicant for MAMMI?

The FDA 510(k) record lists General Equipment For Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMI?

The FDA product code for MAMMI is KPS.

Related Devices (Code: KPS)

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.

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.