MAGNETOM Sola
GUDID 04056869217864
MRI Scanner
Siemens Healthcare GmbH
Full-body MRI system, superconducting magnet| Primary Device ID | 04056869217864 |
| NIH Device Record Key | cc8f44fa-c0d7-4415-9a54-709fc82f8181 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAGNETOM Sola |
| Version Model Number | 11410231 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869217864 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192496
FDA Product Code
| LNI | System, nuclear magnetic resonance spectroscopic |
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 | 2021-07-19 |
| Device Publish Date | 2021-07-09 |
On-Brand Devices [MAGNETOM Sola]
| 04056869164809 | MRI Scanner |
| 04056869217864 | MRI Scanner |
Trademark Results [MAGNETOM Sola]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM SOLA 79235357 not registered Live/Pending |
Siemens Healthcare GmbH 2018-05-18 |
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