Drystar 5302
Catalogue number 5366/100, listed by Agfa Healthcare Inc., Canada, under Camera, Multi Format, Radiological. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
2recalls on this 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 | Agfa Healthcare Inc., Canada |
|---|---|
| FDA product code | LMC |
| Device type | Camera, Multi Format, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K032635 |
| Record published | 2016-09-01 |
| Record revised | 2019-06-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5366/100 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072680 | 2007-10-25 |
| K052251 | 2005-08-31 |
| K032635 | 2003-09-24 |
| K023287 | 2002-10-22 |
| K022658 | 2002-09-06 |
| K012941 | 2001-11-29 |
| K012010 | 2001-09-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-05-16 | Not classified | Other | The “Film Calibration” setting on the printers was set to the default “OFF” position instead of “ON”. | 33 units | 2008-10-10 |
| 2003-11-25 | Not classified | Other | The GS1 circuit board may fail resulting in smoke or fire. | The units were distributed to hospitals and other health fac | 2004-10-01 |
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.