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Sign in to claim this brandPermedics, Inc.
US
Last updated May 30, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Permedics, Inc. primarily manufacture?
Permedics, Inc. specializes in radiation therapy software. Their products focus on improving treatment planning and delivery in cancer care, such as real-time dose calculation and adaptive radiotherapy systems. Examples include the Odyssey and OPTIRAD platforms, which enhance precision in radiation treatment workflows.
Where is Permedics, Inc. based, and how does that affect its regulatory oversight?
Permedics, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since they develop Class II medical devices, these products must comply with FDA requirements, including 510(k) clearance and UDI registration, to ensure safety and effectiveness in radiation therapy applications.
Which regulatory registries list Permedics, Inc.’s devices, and why does this matter?
Permedics, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. This matters because inclusion in these registries confirms that the devices have undergone FDA review and are authorised for use in the US, ensuring compliance with medical device regulations.
How are Permedics, Inc.’s devices classified by the FDA, and what does that classification mean?
Permedics, Inc.’s devices fall under FDA Class II classification, which indicates they pose moderate risk and require special controls beyond general controls to ensure safety and performance. This classification means the company must follow specific regulatory pathways, such as 510(k) pre-market submissions, to demonstrate compliance before devices can be marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- permedics.com
- —
- —
- [email protected]
- Phone
- (909) 478-5000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 073238441
Catalogue (4)
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Permedics, Inc. has two FDA recall records, both initiated in 2010—one on March 23 and the other on November 4. Both records are marked as terminated. The reasons cited involve technical anomalies: the first relates to invalid data exports for DICOM RT Ion, DICOM Image, and RTP Link files, specifically issues with beam table or collimator angle values; the second concerns invalid characters in patient IDs, where non-alphanumeric characters were removed during data processing.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 4, 2010 | Z-0345-2012 | — | 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 |
| Mar 23, 2010 | Z-1609-2010 | — | 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 |