0.6/1.2p324dk-125

FDA UDI

Class I (US FDA UDI)

by Shimadzu Corp.

Identity

Trade Name: 0.6/1.2P324DK-125 FDA UDI
Generic Name: X-ray tube housing assembly, diagnostic FDA UDI
Model / Reference: 582-24490 FDA UDI

Identifiers

Primary DI / UDI-DI: 04540217046553 FDA UDI
FDA Product Code: ITY FDA UDI
GMDN Term: X-ray tube housing assembly, diagnostic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: X-ray tube housing assembly, diagnostic

0.6/1.2p324dk-125 by Shimadzu Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray tube housing assembly, diagnostic.

RTM 72 H — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA · Class I
Mingwei — MingWei Medical Technology(Suzhou)Co., LTD · Class I
RTM 101 H — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA · Class I
Chronos Imaging LLC — Chronos Imaging, LLC · Class I
XRS-140-7.5K-P — Source-Ray, Inc. · Class I
DR 1817 — Philips Medical Systems GmbH, Dmc · Class I
Mingwei — MingWei Medical Technology(Suzhou)Co., LTD · Class I
SRO 33100 ROT 380 — Philips Medical Systems GmbH, Dmc · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Shimadzu Corp.

Sources (1)

FDA UDI e5dcf582-a2f7-4d6a-a284-631367e03771 32 fields · synced May 30, 2026