Identity
- Trade Name
- TULSA-PRO FDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- TULSA-PRO Positioning System FDA UDI
- Model / Reference
- 106585 FDA UDI
- Description
- TULSA-PRO Positioning System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540281000120 FDA UDI07540281001660 FDA UDI
- 510(k) Number
- K202286 FDA UDI
- FDA Product Code
- PLP FDA UDI
- GMDN Term
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
MR Conditional FDA UDI
Category: Therapeutic oncological/gynaecological ultrasound system
Tulsa-Pro by Profound Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202286 also covers:
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
- TULSA-PRO — Profound Medical Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Profound Medical Inc
Sources (2)
- FDA UDI 4eb848d3-5f7e-457d-a867-01b1c36467fc 34 fields · synced Jun 7, 2026
- FDA UDI 0080d038-7551-455d-875c-bafb2f34964a 34 fields · synced May 26, 2026