SciMoCa
Accelerator, Linear, Medical
Radialogica LLC
The following data is part of a premarket notification filed by Radialogica Llc with the FDA for Scimoca.
Pre-market Notification Details
| Device ID | K180595 |
| 510k Number | K180595 |
| Device Name: | SciMoCa |
| Classification | Accelerator, Linear, Medical |
| Applicant | Radialogica LLC 511 N. 511 N. Garrison Avenue Saint Louis, MO 63103 |
| Contact | Debra Vigil |
| Correspondent | Debra Vigil Radialogica LLC 511 N. 511 N. Garrison Avenue Saint Louis, MO 63103 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019946604 | K180595 | 000 |
Trademark Results [SciMoCa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCIMOCA 87982472 not registered Live/Pending |
Radialogica LLC 2017-10-31 |
 SCIMOCA 87666441 not registered Live/Pending |
Radialogica LLC 2017-10-31 |
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