← Back to catalogue

Vscan

FDA UDI

Class II (US FDA UDI)

by Ge Vingmed Ultrasound

Identity

Trade Name
Vscan FDA UDI
Generic Name
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
Vscan Air CL A1 FDA UDI
Model / Reference
Air CL A1 FDA UDI
Description
Vscan Air CL A1 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682147484 FDA UDI
510(k) Number
K202035 FDA UDI
FDA Product Code
IYO FDA UDI
ITX FDA UDI
IYN FDA UDI
GMDN Term
Hand-held ultrasound imaging system, body-surface FDA UDI

Classification

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

No

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: Hand-held ultrasound imaging system, body-surface

Vscan by Ge Vingmed Ultrasound — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held ultrasound imaging system, body-surface.

Cleared under the same submission

K202035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ge Vingmed Ultrasound

Sources (1)

  • FDA UDI 52ffb806-3243-40d7-b4aa-37c47881e2e3 36 fields · synced May 30, 2026