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Optima

FDA UDI

Class II (US FDA UDI)

by GE Hualun Medical Systems Co., Ltd

Identity

Trade Name
Optima FDA UDI
Generic Name
Stationary angiographic x-ray system, digital FDA UDI
Device Name
Optima IGS Ultra UDI FDA UDI
Model / Reference
IGS Ultra FDA UDI
Description
Optima IGS Ultra UDI FDA UDI

Identifiers

Primary DI / UDI-DI
00195278524904 FDA UDI
510(k) Number
K181403 FDA UDI
FDA Product Code
IZI FDA UDI
OWB FDA UDI
JAA FDA UDI
GMDN Term
Stationary angiographic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1600 FDA UDI
892.1650 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: Stationary angiographic x-ray system, digital

Optima by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary angiographic x-ray system, digital.

Cleared under the same submission

K181403 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GE Hualun Medical Systems Co., Ltd

Sources (1)

  • FDA UDI f07cd8f7-f775-4f92-9a6b-fcb5d2d733e1 34 fields · synced May 30, 2026