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Dx-D 400

FDA UDI

Class II (US FDA UDI)

by Agfa Corp.

Identity

Trade Name
DX-D 400 FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
DX-D 400 DIGITAL MANUAL (D) FDA UDI
Model / Reference
5420/101 FDA UDI
Description
DX-D 400 DIGITAL MANUAL (D) FDA UDI

Identifiers

Catalog Number
5U68J FDA UDI
Primary DI / UDI-DI
05414904125571 FDA UDI
510(k) Number
K012546 FDA UDI
FDA Product Code
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, digital 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

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 basic diagnostic x-ray system, digital

Dx-D 400 by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, digital.

Cleared under the same submission

K012546 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 dc08b66b-d583-4ad0-92de-36f95631ad40 36 fields · synced May 30, 2026