Drypix Lite

The DRYPIX Lite is a printer that prints onto film images received via the DICOM network from modalities such as FCR image readers and CT or MRI scanners. The DRYPIX Lite can also be used…

Registry build 21.09.26

The DRYPIX Lite is a printer that prints onto film images received via the DICOM network from modalities such as FCR image readers and CT or MRI scanners. The DRYPIX Lite can also be used to print onto film images from modalities or image processors that are not on the DICOM network.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LMC
Manufacturer City Province Registered as Device types
Qisda Electronics (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Fujifilm Imaging System (Suzhou) Co., Ltd. Suzhou Jiangsu Manufacturer 3

Record

Regulatory record for Drypix Lite
Listed by Fujifilm Corporation, Japan
FDA product code LMC
Device type Camera, Multi Format, Radiological
Device class Class 2
Regulation 21 CFR 892.2040
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K962967
Record published 2016-09-16
Record revised 2024-05-30 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment atmospheric pressure 75 to 106 KiloPascal; Storage environment temperature -10 to 50 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment temperature 15 to 30 °C; Handling environment humidity 15 to 70 % RH

Catalogue Numbers

Catalogue numbers for Drypix Lite
Catalogue number Size Status
DRYPIX 2000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fuji Medical DRY Film Fujifilm Corporation 13
Sony Sony Corporation 9
Codonics Horizon® Multi-media Imager Codonics, Inc. 7
Dryview 5700 Laser Imaging System Carestream Health, Inc. 4
Dryview 5950 Laser Imaging System Carestream Health, Inc. 4
Codonics Horizon® Operating Software Codonics, Inc. 4
Drypro Model 873 Konica Minolta, Inc. 3
Drypro Model 832 Konica Minolta, Inc. 2
Drypix Plus Fujifilm Corporation 2
Drypro Sigma Konica Minolta, Inc. 2
Drypro Sigma 2 Konica Minolta, Inc. 2
Dryview 6950 Laser Imaging System Carestream Health, Inc. 2

Showing 12 of 29. All products under Camera, Multi Format, Radiological

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer