Optivus Proton Therapy, Inc.

San Bernardino, CA, US

OPTIVUS PROTON THERAPY, INC. appears in FDA device records in San Bernardino, CA. FDA records list 2 510(k) clearances between 2000-06-02 and 2005-01-12, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Optivus Proton Therapy, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Permedics, Inc.510(k), recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Optivus Proton Therapy, Inc. between 2000 and 2005. The busiest year on record is 2000, with 1. The most recent is 2005, with 1.

Clearances by year, as a table

510(k) clearance decisions for Optivus Proton Therapy, Inc., by decision year
Year	Clearances
2000	1
2005	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K042861	ODYSSEY	MUJ	Substantially Equivalent	2005-01-12
K993895	OPTIRAD	MUJ	Substantially Equivalent	2000-06-02

Registered establishments

FDA registered establishments for Optivus Proton Therapy, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2032229	3003166990	OPTIVUS PROTON THERAPY, INC.	1475 Victoria Ct, SAN BERNARDINO, CA 92408 US	2026	LHN

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0345-2012	Odyssey A radiation treatment planning system	Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values t		2010-11-04	Terminated
Z-1609-2010	Odyssey Intended use: Radiation treatment planning system	Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter or number (including spaces). Odyssey removes the invalid character when moving it to a patient folder. Due to this, it is possible that two different patient studies could be listed within Odyssey		2010-03-23	Terminated

Verification record

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