510(k) K251650
K251650 is an FDA 510(k) premarket notification submitted by Imaging Engineering, LLC for the device "Insight Enhanced DRF (EN-1002-01)". The FDA issued a decision of Substantially Equivalent on September 16, 2025. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Imaging Engineering, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2025
- Date Received
- May 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type