Permedics, Inc.
United StatesFDA applicant, unverified
Permedics, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) and 2 FDA recalls as of 13 Nov 2026.
- Devices
- 4
- FDA recalls
- 2
Registry facts
- Registries
- FDA 510(k) 2
- FDA GUDID 2
- Device classes
- FDA Class II 4
- FDA recalls
- Identifiers
- DUNS 073238441
At a glance
Market reach
- United States
- FDA recalls
What Permedics, Inc. makes
Permedics, Inc. develops radiation therapy software designed to optimize treatment planning and delivery for medical facilities. Their products include systems for real-time dose calculation and adaptive radiotherapy, such as the Odyssey and OPTIRAD platforms, which support precision in cancer treatment workflows.
The company’s portfolio is classified under FDA Class II devices and is authorised through 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system. These products are regulated under US medical device laws and are listed in the FDA’s official registries.
Catalogue
Company details
- DUNS number
- 073238441
- Phone
- (909) 478-5000
FDA recalls
FDA recall records list 2 recalls initiated by Permedics, Inc., the earliest on 2010-03-23 and the most recent on 2010-11-04. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 4 Nov 2010 Z-0345-2012 Unclassified (pre-2012) Terminated 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
- 23 Mar 2010 Z-1609-2010 Unclassified (pre-2012) Terminated 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
Frequently asked questions
How many devices does Permedics, Inc. have in the registry?
The registry currently lists 4 devices for Permedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Permedics, Inc.'s devices?
Among its 4 most recently registered devices, Permedics, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Permedics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Permedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Permedics, Inc.?
FDA recall records list 2 recalls initiated by Permedics, Inc., the most recent initiated on 4 Nov 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Permedics, Inc. in the registry?
The most recently registered devices listed for Permedics, Inc. include Odyssey 5.2.01, Odyssey 5.2.00, OPTIRAD and ODYSSEY.