FDA 510(k)

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

K-Number: K171303 · 2017-09-22

ApplicantUniversity of Texas Medical School AT Houston, Texas

Decision Date2017-09-22

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is a medical device manufactured by University of Texas Medical School AT Houston, Texas. It received FDA 510(k) clearance on 2017-09-22 under approval number K171303. 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 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is a medical device that received FDA 510(k) clearance on 2017-09-22. It is manufactured by University of Texas Medical School AT Houston, Texas. The 510(k) number is K171303.

When was Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 approved by the FDA?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 received FDA 510(k) clearance on 2017-09-22, under approval number K171303.

What company makes Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is manufactured by University of Texas Medical School AT Houston, Texas.

What is the FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 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 NCT07226869 Computer Guided Microwave Liver Ablation 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

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) PMID: 41298848 FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges. Npj mental health research (2025) PMID: 41124399 Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study. JMIR formative research (2025)

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

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.