Insight Enhanced™ DRF (EN-1002-01)

FDA 510(k) K251650 · Imaging Engineering, LLC

Substantially Equivalent

510(k) numberK251650

Submission

Device name
Insight Enhanced™ DRF (EN-1002-01)
Applicant
Imaging Engineering, LLC
Gainesville, FL, US
Received
May 29, 2025
Decision date
September 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

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K242948Adora DRFi (04550010)JAA · Traditional Nrt X-Ray A/S12/23/2024SE
K233380TRIDENT Mobile Fluoroscopy SystemJAA · Traditional Dornier Medtech America06/26/2024SE
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special Philips Medical Systems Dmc GmbH01/11/2024SE
K232910CombiDiagnost R90JAA · Special Philips Medical Systems Dmc GmbH10/19/2023SE
K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special Canon Medical Systems Corporation09/12/2023SE
K220871NautilusJAA · Special Dornier Medtech America, Inc.04/18/2022SE
K212890Nyquist.IQJAA · Traditional Omega Medical Imaging, LLC12/13/2021SE
K212837ProxiDiagnost N90JAA · Special Philips Medical Systems Dmc GmbH09/21/2021SE

More from Philips Medical Systems Dmc GmbH

510(k)DeviceDecision
K210469Insight Agile DRFJAA · Traditional 07/27/2021SE
K200396Insight Enhanced DRF Digital Imaging SystemJAA · Special 03/06/2020SE
K191310Insight Essentials DRF Digital Imaging SystemJAA · Traditional 06/10/2019SE

Questions and answers

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

Insight Enhanced™ DRF (EN-1002-01) (K251650) received a 510(k) decision of Substantially Equivalent on September 16, 2025, 110 days after the submission was received.

What is the product code of K251650?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.