NAEOTOM Alpha
GUDID 04056869263168
Siemens Healthcare GmbH
Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system| Primary Device ID | 04056869263168 |
| NIH Device Record Key | c6249b5d-bb2a-41e0-b597-895492fed09a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NAEOTOM Alpha |
| Version Model Number | 11330003 |
| Company DUNS | 313217003 |
| Company Name | Siemens Healthcare GmbH |
| 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 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| Phone | +1(800)888-7436 |
| XX@XX.XX | |
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869263168 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211591
FDA Product Code
| JAK | System, x-ray, tomography, computed |
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 | 2021-10-21 |
| Device Publish Date | 2021-10-13 |
Devices Manufactured by Siemens Healthcare GmbH
| 04056869996172 - AI-Rad Companion (Pulmonary) | 2024-04-15 |
| 04056869964331 - AI-Rad Companion (Pulmonary) | 2024-04-09 |
| 04056869961491 - MAGNETOM Terra.X | 2024-04-03 |
| 04056869973135 - MAGNETOM Terra.X Upgrade | 2024-04-03 |
| 04056869975238 - MAGNETOM Cima.X Fit | 2024-03-13 |
| 04056869991269 - syngo Virtual Cockpit | 2024-01-24 |
| 04056869985947 - Syngo Carbon Clinicals | 2024-01-11 |
| 04056869964546 - syngo Application Software | 2024-01-09 syngo Application Software VE3 |
Trademark Results [NAEOTOM Alpha]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAEOTOM ALPHA 79314444 not registered Live/Pending |
Siemens Healthcare GmbH 2021-04-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.