Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Insight Enhanced™ DRF (EN-1002-01)

K-Number: K251650 · 2025-09-16

ApplicantImaging Engineering, LLC
Decision Date2025-09-16
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Insight Enhanced™ DRF (EN-1002-01) is a medical device manufactured by Imaging Engineering, LLC. It received FDA 510(k) clearance on 2025-09-16 under approval number K251650. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insight Enhanced™ DRF (EN-1002-01)?

Insight Enhanced™ DRF (EN-1002-01) is a medical device that received FDA 510(k) clearance on 2025-09-16. It is manufactured by Imaging Engineering, LLC. The 510(k) number is K251650.

When was Insight Enhanced™ DRF (EN-1002-01) approved by the FDA?

Insight Enhanced™ DRF (EN-1002-01) received FDA 510(k) clearance on 2025-09-16, under approval number K251650.

What company makes Insight Enhanced™ DRF (EN-1002-01)?

Insight Enhanced™ DRF (EN-1002-01) is manufactured by Imaging Engineering, LLC.

What is the FDA product code for Insight Enhanced™ DRF (EN-1002-01)?

The FDA product code for Insight Enhanced™ DRF (EN-1002-01) is JAA.

Related Clinical Trials

NCT05281731 Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma RECRUITING NCT07448259 Artificial Intelligence-Assisted Learning for Nursing Drug Calculation COMPLETED

Other Devices by Imaging Engineering, LLC

K191310Insight Essentials DRF Digital Imaging System K200396Insight Enhanced DRF Digital Imaging System K210469Insight Agile DRF

Related Devices (Code: JAA)

K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

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.

↑