Dryview 5950 Laser Imaging System
Dryview 5950 Laser Imager/M/120V
2manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Carestream Health, Inc., United States |
|---|---|
| FDA product code | LMC |
| Device type | Camera, Multi Format, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2021-06-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2021-06-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRYVIEW 5950 Laser Imaging System | In distribution | |
| DRYVIEW 5950 Laser Imaging System | In distribution | |
| DRYVIEW 5950 Laser Imaging System | In distribution | |
| DRYVIEW 5950 Laser Imaging System | Withdrawn |
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 |
| 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 |
| Drypix Smart | Fujifilm Corporation | 2 |
Showing 12 of 29. All products under Camera, Multi Format, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111566 | 2011-10-06 |
| K090469 | 2009-05-22 |
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.