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Dr-Id 1305se

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
DR-ID 1305SE FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
The DR-ID 1305SE incorporates a GOS indirect panel. FDA UDI
Model / Reference
DR-ID 1305 SE E FDA UDI
Description
The DR-ID 1305SE incorporates a GOS indirect panel. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410322927 FDA UDI
510(k) Number
K152138 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-Id 1305se by FUJIFILM Corporation — 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

K152138 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI e61180b3-2333-4391-bb45-d9e0522749f6 37 fields · synced May 30, 2026