Codonics Horizon® G2 Multi-Media Imager
Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 2 Media Input
2manufacturers in China registered for this device type
1catalogue number
6510(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 | Codonics, Inc., United States |
|---|---|
| FDA product code | LMC |
| Device type | Camera, Multi Format, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2040 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K021054 |
| Record published | 2016-08-23 |
| Record revised | 2020-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2 | 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 |
|---|---|
| K060440 | 2006-03-16 |
| K042232 | 2004-10-05 |
| K030690 | 2003-04-30 |
| K021054 | 2002-05-09 |
| K003481 | 2001-01-19 |
| K962364 | 1996-11-08 |
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.