← Back to catalogue

Digital Expert Access

FDA UDI

Class II (US FDA UDI)

by GE Healthcare

Identity

Trade Name
Digital Expert Access FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
DE Modality Connectivity Executable FDA UDI
Model / Reference
1 FDA UDI
Description
DE Modality Connectivity Executable FDA UDI

Identifiers

Primary DI / UDI-DI
00195278263919 FDA UDI
510(k) Number
K150193 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

Digital Expert Access by GE Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
GE Healthcare

Sources (1)

  • FDA UDI 8852431d-c1bb-443a-b6dd-145fdf329fa8 34 fields · synced May 31, 2026