510(k) K241094
K241094 is an FDA 510(k) premarket notification submitted by Turing Medical Technologies, Inc. for the device "Bullsai". The FDA issued a decision of Substantially Equivalent on Aug 13, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Turing Medical Technologies, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2024
- Date Received
- Apr 22, 2024
- 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
- 510(k)