Ultrasound System SONIMAGE HS1

FDA UDI

Class II (US FDA UDI)

by Konica Minolta, Inc.

Identity

Trade Name: Ultrasound System SONIMAGE HS1 FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Model / Reference: A8WA FDA UDI

Identifiers

Primary DI / UDI-DI: 04560141944534 FDA UDI
510(k) Number: K152577 FDA UDI
FDA Product Code: IYN FDA UDI
IYO 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
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General-purpose ultrasound imaging system

Ultrasound System SONIMAGE HS1 by Konica Minolta, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152577 also covers:

Linear Probe L14-4 — Konica Minolta, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Konica Minolta, Inc.

Sources (1)

FDA UDI 3c055dad-c2ad-445e-b719-66ba0935f787 33 fields · synced Jun 1, 2026