510(k) K222577
K222577 is an FDA 510(k) premarket notification submitted by Techfit Digital Surgery, Inc. for the device "TECHFIT Diagnostic Models". The FDA issued a decision of Substantially Equivalent on January 6, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Techfit Digital Surgery, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2023
- Date Received
- August 25, 2022
- 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