Drypix Smart
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.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| 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
| 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) | K033377 |
| Record published | 2024-06-07 |
| Record revised | 2024-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 15 to 70 % RH; Storage environment temperature -10 to 50 °C; Handling environment temperature 15 to 30 °C; Storage environment atmospheric pressure 75 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRYPIX SMART II : E | In distribution | |
| DRYPIX 6000 | In distribution |
Same 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.