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FDA 510(k)

HeartSee Cardiac P.E.T. Processing Software

K-Number: K181343 · 2018-06-12

ApplicantBracco Diagnostics, Inc.
Decision Date2018-06-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HeartSee Cardiac P.E.T. Processing Software is a medical device manufactured by Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-12 under approval 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. It is manufactured by Bracco Diagnostics, Inc.. The 510(k) number is K181343.

When was HeartSee Cardiac P.E.T. Processing Software approved by the FDA?

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

What company makes HeartSee Cardiac P.E.T. Processing Software?

HeartSee Cardiac P.E.T. Processing Software is manufactured by Bracco Diagnostics, Inc..

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.

Related Clinical Trials

NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT07585019 Ventilator Study in the NICU NOT_YET_RECRUITING NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT06034392 CHAMP App Cardiac Study and Repository ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025)

Other Devices by Bracco Diagnostics, Inc.

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

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Official Source

View on FDA Database →

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