510(k) K241713
K241713 is an FDA 510(k) premarket notification submitted by Curvebeam, LLC for the device "HiRise (1040-230)". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Curvebeam, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2024
- Date Received
- June 14, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type