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Dr 14s G Dx-D Imaging Package

FDA UDI

Class II (US FDA UDI)

by Agfa Corp.

Identity

Trade Name
DR 14S G DX-D IMAGING PACKAGE FDA UDI
Generic Name
Flat panel x-ray detector integration unit FDA UDI
Model / Reference
5400/524 FDA UDI

Identifiers

Catalog Number
XBOPM FDA UDI
Primary DI / UDI-DI
05414904222218 FDA UDI
510(k) Number
K161368 FDA UDI
FDA Product Code
MQB FDA UDI
GMDN Term
Flat panel x-ray detector integration unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 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

Yes

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

Dimensions & Sizes

Size
Length — 43 Centimeter FDA UDI
Width — 35 Centimeter FDA UDI

Category: Flat panel x-ray detector integration unit

Dr 14s G Dx-D Imaging Package by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flat panel x-ray detector integration unit.

Cleared under the same submission

K161368 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agfa Corp.

Sources (1)

  • FDA UDI 29b64239-68ac-4e4d-b14f-67b64d5183f4 36 fields · synced Jun 1, 2026