VERITON CT 8010422-01
GUDID 07290108670189
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
SPECT/CT system| Primary Device ID | 07290108670189 |
| NIH Device Record Key | 48e19960-2f92-446a-8d9d-afce46607e26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERITON CT |
| Version Model Number | VERITON CT 464 |
| Catalog Number | 8010422-01 |
| Company DUNS | 078864620 |
| Company Name | SPECTRUM DYNAMICS MEDICAL, INC |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290108670189 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230600
FDA Product Code
| KPS | System, Tomography, Computed, Emission |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
On-Brand Devices [VERITON CT]
| 07290108670110 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
| 07290108670127 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
| 07290108670226 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
| 07290108670219 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
| 07290108670189 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
| 07290108670172 | Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste |
Trademark Results [VERITON CT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERITON CT 87639401 5704303 Live/Registered |
Spectrum Dynamics Medical Limited 2017-10-10 |
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