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Dr 600

FDA UDI

Class II (US FDA UDI)

by Agfa Corp.

Identity

Trade Name
DR 600 FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
DR 600 FULLY AUTOMATIC FDA UDI
Model / Reference
5530/100 FDA UDI
Description
DR 600 FULLY AUTOMATIC FDA UDI

Identifiers

Catalog Number
542VH FDA UDI
Primary DI / UDI-DI
05414904196298 FDA UDI
510(k) Number
K152639 FDA UDI
FDA Product Code
MQB 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

Dr 600 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

K152639 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 ca14f1ec-2e3a-49a9-a156-27702a7e1af5 36 fields · synced Jun 6, 2026