FDA 510(k)

HeartSee Cardiac P.E.T. Processing Software

K-Number: K181343 · 2018-06-12

Decision Date2018-06-12

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HeartSee Cardiac P.E.T. Processing Software is the device name listed in this FDA 510(k) record. The listed applicant is Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K181343. 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 HeartSee Cardiac P.E.T. Processing Software?

HeartSee Cardiac P.E.T. Processing Software is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Bracco Diagnostics, Inc.. The 510(k) number is K181343.

When did HeartSee Cardiac P.E.T. Processing Software receive FDA 510(k) clearance?

HeartSee Cardiac P.E.T. Processing Software received FDA 510(k) clearance on 2018-06-12, under 510(k) number K181343.

Who is the listed applicant for HeartSee Cardiac P.E.T. Processing Software?

The FDA 510(k) record lists Bracco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartSee Cardiac P.E.T. Processing Software?

The FDA product code for HeartSee Cardiac P.E.T. Processing Software is KPS.

Other records listing Bracco Diagnostics, Inc. 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.

K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

Related Devices (Code: KPS)

Official Source

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