MOBILETT Elara Max
System, X-ray, Mobile
Siemens Medical Solutions, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Mobilett Elara Max.
Pre-market Notification Details
| Device ID | K182639 |
| 510k Number | K182639 |
| Device Name: | MOBILETT Elara Max |
| Classification | System, X-ray, Mobile |
| Applicant | Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Contact | Denise Adams |
| Correspondent | Kim Rendon Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-03-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869154992 | K182639 | 000 |
Trademark Results [MOBILETT Elara Max]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOBILETT ELARA MAX 79238629 not registered Live/Pending |
Siemens Healthcare GmbH 2018-06-15 |
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