MOBETRON
System, Radiation Therapy, Charged-particle, Medical
INTRAOP MEDICAL, INC.
The following data is part of a premarket notification filed by Intraop Medical, Inc. with the FDA for Mobetron.
Pre-market Notification Details
| Device ID | K981112 |
| 510k Number | K981112 |
| Device Name: | MOBETRON |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | INTRAOP MEDICAL, INC. 3170 DE LA CRUZ BLVD., #108 Santa Clara, CA 95054 |
| Contact | Donald A Goer |
| Correspondent | Donald A Goer INTRAOP MEDICAL, INC. 3170 DE LA CRUZ BLVD., #108 Santa Clara, CA 95054 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-26 |
| Decision Date | 1998-07-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861396000308 | K981112 | 000 |
Trademark Results [MOBETRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOBETRON 85479743 4232738 Live/Registered |
INTRAOP MEDICAL CORPORATION 2011-11-23 |
 MOBETRON 75615388 2432157 Dead/Cancelled |
INTRAOP MEDICAL, INC. 1999-01-04 |
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