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FDA 510(k)

Insight Enhanced DRF Digital Imaging System

K-Number: K200396 · 2020-03-06

ApplicantImaging Engineering, LLC
Decision Date2020-03-06
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Insight Enhanced DRF Digital Imaging System is a medical device manufactured by Imaging Engineering, LLC. It received FDA 510(k) clearance on 2020-03-06 under approval number K200396. 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 Digital Imaging System?

Insight Enhanced DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Imaging Engineering, LLC. The 510(k) number is K200396.

When was Insight Enhanced DRF Digital Imaging System approved by the FDA?

Insight Enhanced DRF Digital Imaging System received FDA 510(k) clearance on 2020-03-06, under approval number K200396.

What company makes Insight Enhanced DRF Digital Imaging System?

Insight Enhanced DRF Digital Imaging System is manufactured by Imaging Engineering, LLC.

What is the FDA product code for Insight Enhanced DRF Digital Imaging System?

The FDA product code for Insight Enhanced DRF Digital Imaging System is JAA.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Imaging Engineering, LLC

K191310Insight Essentials DRF Digital Imaging System K210469Insight Agile DRF K251650Insight Enhanced™ DRF (EN-1002-01)

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.

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