510(k) K252199
K252199 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "AGFA HealthCare Enterprise Imaging". The FDA issued a decision of Substantially Equivalent on Oct 15, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Agfa Healthcare N.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2025
- Date Received
- Jul 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type