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Sonic Window Handheld Ultrasound System

FDA UDI

Class II (US FDA UDI)

by Analogic Corporation

Identity

Trade Name
Sonic Window Handheld Ultrasound System FDA UDI
Generic Name
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. FDA UDI
Model / Reference
10-73690-02 FDA UDI
Description
The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. FDA UDI

Identifiers

Primary DI / UDI-DI
90814277020004 FDA UDI
510(k) Number
K140126 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX 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
892.1550 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held ultrasound imaging system, body-surface

Sonic Window Handheld Ultrasound System by Analogic Corporation — 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

K140126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Analogic Corporation

Sources (1)

  • FDA UDI 5ae230f1-aba6-4421-9c54-81a897180704 35 fields · synced Jun 8, 2026