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DRYPIX Smart

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
DRYPIX Smart FDA UDI
Generic Name
Diagnostic-imaging multiformat camera FDA UDI
Device Name
The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or DR, CT, MRI and other imaging modalities, onto a film. FDA UDI
Model / Reference
DRYPIX 6000 FDA UDI
Description
The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or DR, CT, MRI and other imaging modalities, onto a film. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410239300 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

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: Diagnostic-imaging multiformat camera

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

Similar devices

Also classified as Diagnostic-imaging multiformat camera.

Cleared under the same submission

K033377 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 28da9c22-3da0-49c5-97c6-01c5986c4a00 36 fields · synced May 30, 2026