| Primary Device ID | 04987670100116 |
| NIH Device Record Key | cbd1263a-25cd-49b0-be89-f4bcf088c41d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIAGNOSTIC X-RAY SYSTEM KALARE |
| Version Model Number | DREX-KL80 |
| Company DUNS | 690575113 |
| Company Name | CANON MEDICAL SYSTEMS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1-8004211968 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987670100116 [Primary] |
| JAA | System, x-ray, fluoroscopic, image-intensified |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| 04987670100925 - BIOPSY ADAPTOR | 2024-04-22 |
| 04987670104626 - LINEAR ARRAY TRANSDUCER | 2024-04-22 |
| 04987670104633 - LINEAR ARRAY TRANSDUCER | 2024-04-22 |
| 04987670104640 - ENDOCAVITARY TRANSDUCER | 2024-04-22 |
| 04987670104664 - CONVEX ARRAY TRANSDUCER | 2024-04-22 |
| 04987670106033 - CONVEX ARRAY TRANSDUCER | 2024-04-22 |
| 04987670106057 - CONVEX ARRAY TRANSDUCER | 2024-04-22 |
| 04987670100680 - BIOPSY ADAPTOR | 2024-04-16 |