510(k) K230581
K230581 is an FDA 510(k) premarket notification submitted by Neuf, Inc. for the device "TOPA12 Portable X-ray Unit". The FDA issued a decision of Substantially Equivalent on Aug 16, 2023. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Neuf, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2023
- Date Received
- Mar 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)