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HERA W10 Diagnostic Ultrasound System

FDA UDI

Class II (US FDA UDI)

by Samsung Medison Co., Ltd

Identity

Trade Name
HERA W10 Diagnostic Ultrasound System FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Model / Reference
USS-HRW1F4E/US FDA UDI

Identifiers

Primary DI / UDI-DI
08809944937180 FDA UDI
510(k) Number
K242444 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
QIH FDA UDI
LLZ FDA UDI
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
892.2050 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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

HERA W10 Diagnostic Ultrasound System by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K242444 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Samsung Medison Co., Ltd

Sources (1)

  • FDA UDI 9de58660-72e3-4dd5-a4d2-eee6f313d6f2 34 fields · synced May 31, 2026