| Primary Device ID | 00195278722546 |
| NIH Device Record Key | 70bbdb9f-d2fe-4739-afc9-056316168c76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyoSEPCT ES to MyoSPECT Upgrade |
| Version Model Number | H3912BS |
| Catalog Number | 5941445 |
| Company DUNS | 532102365 |
| Company Name | G E MEDICAL SYSTEMS ISRAEL LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278722546 [Primary] |
| KPS | System, tomography, computed, emission |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-22 |
| Device Publish Date | 2023-09-14 |
| 00195278011343 - DaTQUANT | 2026-01-30 |
| 00195278614933 - Xeleris Processing and Review Workstation | 2026-01-30 Xeleris V Clinical Application SW |
| 00195278822383 - Xeleris Processing and Review Workstation | 2026-01-30 Xeleris V Clinical Application SW |
| 00198953061329 - NMCT 860 | 2025-09-17 NM_CT 860 NM Gantry Final MDR |
| 00198953061336 - NMCT 850 | 2025-09-17 NM_CT 850 NM Gantry Final MDR |
| 00195278878502 - Aurora | 2025-03-05 AURORA NM GANTRY FINAL |
| 00195278870490 - StarGuide MDD to MDR Upgrade | 2024-05-24 StarGuide SW and Labels Upgrade |
| 00195278755544 - StarGuide | 2024-04-26 StarGuide NM GANTRY MDR FINAL |