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Tulsa-Pro

FDA UDI

Class II (US FDA UDI)

by Profound Medical Inc

Identity

Trade Name
TULSA-PRO FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
CABLE - UA TO PSIB, 123 MHz FDA UDI
Model / Reference
107344 FDA UDI
Description
CABLE - UA TO PSIB, 123 MHz FDA UDI

Identifiers

Primary DI / UDI-DI
07540281001615 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
Not 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
MRI Safety
MR Conditional FDA UDI

Tulsa-Pro by Profound Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K202286 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Profound Medical Inc

Sources (1)

  • FDA UDI e87fe1dd-a67d-4645-aa34-0242beee74a9 35 fields · synced Jun 8, 2026