Intraop Medical Corp.

Fremont, CA, US

INTRAOP MEDICAL CORP. appears in FDA device records in Fremont, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Intraop Medical Corp. in 1998.

Clearances by year, as a table

510(k) clearance decisions for Intraop Medical Corp., by decision year
Year	Clearances
1998	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K981112	MOBETRON	LHN	Substantially Equivalent	1998-07-24

Registered establishments

FDA registered establishments for Intraop Medical Corp., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2953704	3001874253	INTRAOP MEDICAL CORP.	448 Kato Ter, Fremont, CA 94539 US	2026	LHN

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

LHNSystem, Radiation Therapy, Charged-Particle, Medical

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0014-2009	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.		2008-06-20	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain