FDA.report

510(k) K251650

Device
Insight Enhanced™ DRF (EN-1002-01)
Applicant
Imaging Engineering, LLC
510(k) number
K251650
Product code
JAA
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-16
Date received
2025-05-29
Regulation
892.1650
Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
George Jachode
Address
4424 NW 13th St. Suite B12 Gainesville FL US 32609 32609

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH2020-12-03