Tulsa-Pro 106583
by Profound Medical Inc 2 variants
Tulsa-Pro 106583 is a Class II device made by Profound Medical Inc, cleared under FDA 510(k) K202286 on 16 Sep 2020 and listed in FDA GUDID since 25 Sep 2020 (UDI-DI 07540281000892), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540281000892 | Date25 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202286 | Date16 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 07540281000892
- FDA 510(k) database K202286
Across registries
- FDA 510(k) K202286 decided 16 Sep 2020 Active
- FDA GUDID UDI-DI 07540281000892 listed 25 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K202286
- Listed FDA GUDID 07540281000892
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tulsa-Pro
- Generic name
- Therapeutic oncological/gynaecological ultrasound system
- Model / reference
- 106583
- Primary DI / UDI-DI
- 07540281000892
- 510(k) Number
- FDA product code
- PLP
- GMDN term
- Therapeutic oncological/gynaecological ultrasound system
- Device class
- Class II
- Regulation number
- 876.4340
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe