Biograph Vision.X
GUDID 04056869996639
SIEMENS MEDICAL SOLUTIONS USA, INC.
PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system| Primary Device ID | 04056869996639 |
| NIH Device Record Key | a3008499-fc2e-49e1-b1cb-5649cdffd0ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biograph Vision.X |
| Version Model Number | 11713176 |
| Company DUNS | 868230876 |
| Company Name | SIEMENS MEDICAL SOLUTIONS USA, 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 | 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 |
Customer Support Contacts
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869996639 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231833
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 | 2023-11-20 |
| Device Publish Date | 2023-11-10 |
Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.
| 04056869961064 - Sparrow HP2 3 Ring | 2024-02-08 |
| 04056869961071 - Sparrow HP2 4 Ring | 2024-02-08 |
| 04056869961088 - Sparrow HP4 3 Ring | 2024-02-08 |
| 04056869961095 - Sparrow HP4 4 Ring | 2024-02-08 |
| 04056869973852 - 5Z1 Transducer | 2024-01-25 |
| 04056869973869 - Z6T Transducer | 2024-01-25 |
| 04056869996295 - ACUSON Origin Diagnostic Ultrasound System | 2023-12-27 |
| 04056869279800 - syngo MBF | 2023-12-15 |
Trademark Results [Biograph Vision.X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOGRAPH VISION.X 98174063 not registered Live/Pending |
Siemens Medical Solutions USA, Inc. 2023-09-11 |
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