Multitom Rax
GUDID 04056869009179
Interventional Fluoroscopy
Siemens Healthcare GmbH
Stationary general-purpose fluoroscopic x-ray system, digital| Primary Device ID | 04056869009179 |
| NIH Device Record Key | 791ff219-c6a7-4ce7-83c8-d51e0cc61b7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multitom Rax |
| Version Model Number | 10860700 |
| 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50000 KiloPascal and 106000 KiloPascal |
| Storage Environment Temperature | Between 20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869009179 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152928
FDA Product Code
| OWB | Interventional fluoroscopic x-ray system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Siemens Healthcare GmbH
| 04068151036749 - MAGNETOM Flow.Rise | 2026-01-28 |
| 04056869299556 - MAGNETOM Flow.Neo | 2026-01-27 |
| 04056869299594 - MAGNETOM Flow.Neo | 2026-01-27 |
| 04068151034196 - MAGNETOM Flow.Elite | 2026-01-27 |
| 04068151036732 - MAGNETOM Flow.Elite | 2026-01-27 |
| 04068151047943 - MAGNETOM Flow.Neo | 2026-01-27 |
| 04068151047950 - MAGNETOM Flow.Elite | 2026-01-27 |
| 04056869299297 - MAMMOVISTA B.smart | 2026-01-26 Medical software that provides workflow, reading and reporting support on clinical images |
Trademark Results [Multitom Rax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTITOM RAX 79188057 5238589 Live/Registered |
Siemens Healthcare GmbH 2016-02-26 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.