DRX Plus 4343 Detector
DRX Plus 4343 portable grid holder
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Bioway Medical Technology Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
Record
| Listed by | Carestream Health, Inc., United States |
|---|---|
| FDA product code | IXJ |
| Device type | Grid, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K090318 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRX Plus 4343 DETECTOR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MS X-RAY Grid | Mitaya Manufacturing Co., Ltd. | 153 |
| Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm)) | JPI Healthcare Co., Ltd. | 10 |
| Grid, Radiographic | Samsung Electronics Co., Ltd. | 7 |
| GuideLines | Beekley Corporation | 4 |
| True Speed Bucky | Carestream Health, Inc. | 3 |
| MS-LD Grid | Mitaya Manufacturing Co., Ltd. | 3 |
| Radiographic grid | JPI Healthcare Co., Ltd. | 3 |
| Grid Facile | Mitaya Manufacturing Co., Ltd. | 3 |
| Grid Landscape for SkyPlate large | Philips Medical Systems DMC GmbH | 3 |
| Grid Portrait for SkyPlate large | Philips Medical Systems DMC GmbH | 3 |
| X-Ray Grid 40/8/110 | Philips Medical Systems DMC GmbH | 2 |
| Directview CR Gridded Cassette with PQ Screen | Carestream Health, Inc. | 2 |
Showing 12 of 70. All products under Grid, Radiographic
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.