| Primary Device ID | 00195278723963 |
| NIH Device Record Key | 219ff6b9-eadf-4510-8d61-df14edc0c5c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6Sc-D |
| Catalog Number | H46462LS |
| Company DUNS | 696021596 |
| Company Name | GE Healthcare Japan 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278723963 [Primary] |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2025-10-15 |
| 00195278723963 - NA | 2026-01-306Sc-D |
| 00195278723963 - NA | 2026-01-30 6Sc-D |
| 00195278718129 - Revolution | 2024-05-03 Ascend Elite Gantry common top asm with UDI |
| 00195278718136 - Revolution | 2024-05-03 Ascend Plus Gantry common top asm with UDI |
| 00195278718204 - Revolution | 2024-05-03 Ascend Select Gantry common top asm with UDI |
| 00195278620453 - DLIR | 2023-07-10 SWMD DLIR Application for Smart Subscription |
| 00195278303196 - ASiR-V | 2021-09-02 ASiR-V Application Container for Smart Subscription |
| 00195278303202 - DLIR | 2021-09-02 DLIR Application Container for Smart Subscription |
| 00195278303219 - MAR | 2021-09-02 MAR Application Container for Smart Subscription |