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Sonosite PX Mounting Solution

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref P32009-01Model SONOSITE PX ULTRASOUND SYSTEM

by Fujifilm Sonosite, Inc.

Identity

Trade Name
Sonosite PX Mounting Solution EUDAMEDFDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
SONOSITE PX ULTRASOUND SYSTEM EUDAMED
Diagnostic Ultrasound Accessory FDA UDI
Model / Reference
SONOSITE PX ULTRASOUND SYSTEM EUDAMED
P32009-01 EUDAMEDFDA UDI
Description
Diagnostic Ultrasound Accessory FDA UDI

Identifiers

Catalog Number
P32009 FDA UDI
Primary DI / UDI-DI
00841517109653 EUDAMEDFDA UDI
Basic UDI-DI
08415171PX8P EUDAMED
510(k) Number
K200964 FDA UDI
K213763 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
IYO FDA UDI
EMDN Code
Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 FDA UDI
892.1560 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Sonosite PX Mounting Solution by Fujifilm Sonosite, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Fujifilm Sonosite, Inc.
EUDAMED SRN
US-MF-000001075
Authorised Representative
Fujifilm Sonosite B.V. NL-AR-000000046

Sources (3)

  • EUDAMED 25e98dda-22ce-4453-b324-5a4675d93ebe 61 fields · synced Jun 19, 2026
  • FDA UDI 0894aed2-8738-4fd1-8af7-d09f1217bcc4 36 fields · synced May 30, 2026
  • FDA 510(k) K213763 1 fields · synced May 18, 2026