Data / Medical devices / United States / Intraop Medical Corp.
Intraop Medical Corp.: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance
Intraop Medical Corp. is registered with the FDA (registration 2953704) in Fremont, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 24, 1998. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2953704
- FEI number
- 3001874253
- Address
- 448 Kato Ter, Fremont, CA, United States, 94539
- Owner or operator
- INTRAOP MEDICAL CORP. (9011205)
- Roles
- Manufacturer
- First device listed
- January 24, 2008
- Registered through
- 2026
- Brand names listed
- MOBETRON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 1998 | K981112 | MOBETRON | LHN | Substantially Equivalent | Intraop Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 20, 2008 | 49022 | Not yet classified | Terminated | Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site. | Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient. | accessdata.fda.gov |
Compare with other makers
Updated October 3, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.