Grid, Radiographic
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician.…
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
1manufacturer
7catalogue numbers in this listing
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 | Samsung Electronics Co., Ltd., South Korea |
|---|---|
| FDA product code | IXJ |
| Device type | Grid, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1910 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140326 |
| Record published | 2016-11-18 |
| 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 |
|---|---|---|
| Grid 7 | In distribution | |
| Grid 2 | In distribution | |
| Grid 1 | In distribution | |
| Grid 6 | In distribution | |
| Grid 4 | In distribution | |
| Grid 3 | In distribution | |
| Grid 5 | 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 |
| 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 |
| Box for radiographic Grid-1000(for connection(outside 962mmx495mm)) | JPI Healthcare Co., Ltd. | 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.