DAR-8000i

FDA UDI

Class II (US FDA UDI)

by Shimadzu Corp.

Identity

Trade Name: DAR-8000i FDA UDI
Generic Name: Stationary angiographic x-ray system, digital FDA UDI
Model / Reference: 502-24400-12 FDA UDI

Identifiers

Primary DI / UDI-DI: 04540217011469 FDA UDI
510(k) Number: K052076 FDA UDI
FDA Product Code: LLZ FDA UDI
IZI FDA UDI
GMDN Term: Stationary angiographic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1600 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary angiographic x-ray system, digital

DAR-8000i by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Stationary angiographic x-ray system, digital.

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Cleared under the same submission

K052076 also covers:

DAR-8000i — Shimadzu Corp.

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 II	Pending data

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Manufacturer

Manufacturer: Shimadzu Corp.

Sources (1)

FDA UDI aa1f1bff-6d38-4b00-83c0-52abe2f83dc0 33 fields · synced Jun 6, 2026