DRYPIX Plus

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: DRYPIX Plus FDA UDI
Generic Name: Diagnostic-imaging multiformat camera FDA UDI
Device Name: The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format. FDA UDI
Model / Reference: DRYPIX 4000 FDA UDI
Description: The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410180060 FDA UDI
510(k) Number: K033377 FDA UDI
FDA Product Code: LMC FDA UDI
GMDN Term: Diagnostic-imaging multiformat camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2040 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

Yes

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: Diagnostic-imaging multiformat camera

DRYPIX Plus by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic-imaging multiformat camera.

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FLUOBEAM 800 — FLUOPTICS · Class II
ACTEON — SOPRO · Class II
ACTEON — SOPRO · Class II
ACTEON — SOPRO · Class II
ACTEON — SOPRO · Class II

Cleared under the same submission

K033377 also covers:

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: FUJIFILM Corporation

Sources (1)

FDA UDI 03c36865-92d0-4604-8eb5-7678086f287b 36 fields · synced May 30, 2026