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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 the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2025-09-16 under 510(k) 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. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K251650.

When did Insight Enhanced™ DRF (EN-1002-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for Insight Enhanced™ DRF (EN-1002-01)?

The FDA 510(k) record lists Imaging Engineering, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Imaging Engineering, LLC 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.

K210469Insight Agile DRFK200396Insight Enhanced DRF Digital Imaging SystemK191310Insight Essentials DRF Digital Imaging System

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbHK232910CombiDiagnost R90Philips Medical Systems Dmc GmbH

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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