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10 MHz probe

FDA UDI

Class II (US FDA UDI)

by Viasonix Ltd

Identity

Trade Name
10 MHz probe FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements. FDA UDI
Model / Reference
10 MHz probe FDA UDI
Description
10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements. FDA UDI

Identifiers

Catalog Number
PVC0332 FDA UDI
Primary DI / UDI-DI
07290016880410 FDA UDI
510(k) Number
K111416 FDA UDI
FDA Product Code
JOP FDA UDI
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2880 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

Yes

FDA UDI

10 MHz probe by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111416 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Viasonix Ltd

Sources (1)

  • FDA UDI 0b3b5ee2-5530-4600-ac95-47564c6f89a5 36 fields · synced May 29, 2026