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Logiq

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref LOGIQ E10s R2R3 to R4 HW Upgrade / 5946722Model LOGIQ E10s

by GE Ultrasound Korea Ltd.

Identity

Trade Name
LOGIQ FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
LOGIQ E10s EUDAMED
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware FDA UDI
Model / Reference
LOGIQ E10s EUDAMED
LOGIQ E10s R2R3 to R4 HW Upgrade / 5946722 EUDAMED
E10s R2R3 to R4 HW Upgrade FDA UDI
Description
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware FDA UDI

Identifiers

Catalog Number
5946722 FDA UDI
Primary DI / UDI-DI
00195278835765 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00033GT EUDAMED
510(k) Number
K231989 FDA UDI
FDA Product Code
IYN FDA UDI
ITX FDA UDI
IYO FDA UDI
EMDN Code
Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1570 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Logiq by GE Ultrasound Korea Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K231989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GE Ultrasound Korea Ltd.

Sources (2)

  • FDA UDI 7992d97c-f523-4e80-b28e-e3c3b958cfec 36 fields · synced Oct 6, 2026
  • EUDAMED 12364169-4592-4b49-b44e-6abb30e70f65 61 fields · synced Jul 17, 2026