510(k) K243447
K243447 is an FDA 510(k) premarket notification submitted by Navbit Pty, Ltd. for the device "Rapid Surgical Plan (RSP-SW-001)". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Navbit Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2024
- Date Received
- November 7, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type