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Sonoscape

FDA UDI

Class II (US FDA UDI)

by Sonoscape Medical Corp.

Identity

Trade Name
Sonoscape FDA UDI
Generic Name
Surgical ultrasound imaging transducer FDA UDI
Device Name
LAP7 Ultrasonic Transducer (P10 Series) FDA UDI
Model / Reference
LAP7 FDA UDI
Description
LAP7 Ultrasonic Transducer (P10 Series) FDA UDI

Identifiers

Primary DI / UDI-DI
06945868602864 FDA UDI
510(k) Number
K173058 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
GMDN Term
Surgical ultrasound imaging transducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1560 FDA UDI
892.1570 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

Category: Surgical ultrasound imaging transducer

Sonoscape by Sonoscape Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical ultrasound imaging transducer.

Cleared under the same submission

K173058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sonoscape Medical Corp.

Sources (1)

  • FDA UDI a54a67cd-859d-43f2-a8b7-1215f04ca97c 34 fields · synced May 30, 2026