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P21x/5-1 MHz

FDA UDI

Class II (US FDA UDI)

by Fujifilm Sonosite, Inc.

Identity

Trade Name
P21x/5-1 MHz FDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Device Name
Diagnostic Ultrasound Transducer FDA UDI
Model / Reference
P24313-02 FDA UDI
Description
Diagnostic Ultrasound Transducer FDA UDI

Identifiers

Primary DI / UDI-DI
00841517106881 FDA UDI
510(k) Number
K071134 FDA UDI
K082098 FDA UDI
K101757 FDA UDI
K130173 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI

Classification

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

Yes

FDA UDI

Category: Extracorporeal ultrasound imaging transducer, hand-held

P21x/5-1 MHz by Fujifilm Sonosite, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Cleared under the same submission

K071134 also covers:

K082098 also covers:

K101757 also covers:

K130173 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujifilm Sonosite, Inc.

Sources (1)

  • FDA UDI d1136bf2-2b1a-4309-81cc-cb7dc1b79dfb 35 fields · synced May 31, 2026