Insight Agile DRF

FDA 510(k) K210469 · Imaging Engineering, LLC

Substantially Equivalent

510(k) numberK210469

Submission

Device name
Insight Agile DRF
Applicant
Imaging Engineering, LLC
Cape Coral, FL, US
Received
February 16, 2021
Decision date
July 27, 2021
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

Other 510(k)s with product code JAA

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K253103Nexus DRF Digital X-ray Imaging SystemJAA · Traditional Varex Imaging Corporation05/29/2026SE
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K242488Soteria E-ViewJAA · Traditional Omega Medical Imaging, LLC01/06/2025SE
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

More from Omega Medical Imaging, LLC

510(k)DeviceDecision
K251650Insight Enhanced™ DRF (EN-1002-01)JAA · Traditional 09/16/2025SE
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 Agile DRF cleared by the FDA?

Insight Agile DRF (K210469) received a 510(k) decision of Substantially Equivalent on July 27, 2021, 161 days after the submission was received.

What is the product code of K210469?

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