Data / Medical devices / United States / Optivus Proton Therapy, Inc.
Optivus Proton Therapy, Inc.: FDA-registered device maker in San Bernardino, CA, United States, 1 510(k) clearance
Optivus Proton Therapy, Inc. is registered with the FDA (registration 2032229) in San Bernardino, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 21, 2000. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2032229
- FEI number
- 3003166990
- Address
- 1475 Victoria Ct, San Bernardino, CA, United States, 92408
- Owner or operator
- OPTIVUS PROTON THERAPY, INC. (9038517)
- Roles
- Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2026
- Brand names listed
- Conforma 3000
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 21, 2000 | K992414 | PROTON BEAM THERAPY SYSTEM (PBTS) | LHN | Substantially Equivalent | Optivus Technology, 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 |
|---|---|---|---|---|---|---|
| November 4, 2010 | 59934 | Not yet classified | Terminated | 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 t | accessdata.fda.gov |
| March 23, 2010 | 55280 | Not yet classified | Terminated | 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 | accessdata.fda.gov |
Compare with other makers
Updated December 1, 2011. 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.