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Sign in to claim this brandSpencer Technologies
US
Last updated May 30, 2026
What Spencer Technologies makes
Spencer Technologies manufactures non-invasive vascular ultrasound systems designed for transcranial Doppler (TCD) imaging, including line-powered devices for blood flow assessment in cerebral vessels. Their portfolio also includes radiology software applications for processing and viewing DICOM images, such as PMD Viewer, alongside specialized TCD transducers like the PWD13.
The company’s devices are classified under FDA Class II regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where Spencer Technologies is based.
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 Spencer Technologies manufacture?
Spencer Technologies specializes in non-invasive vascular ultrasound systems, specifically transcranial Doppler (TCD) devices like the ST3 Digital Transcranial Doppler System. These systems assess blood flow in cerebral vessels without surgery. Additionally, they develop radiology software applications, such as the PMD Viewer, which processes and displays DICOM images for diagnostic use.
Where is Spencer Technologies based, and where are its devices primarily intended for use?
Spencer Technologies is based in the United States. The company’s devices are designed and marketed for use within the US regulatory environment, aligning with FDA requirements for medical device authorization.
Which regulatory registries list Spencer Technologies’ devices?
Spencer Technologies’ devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries document compliance and classification for devices authorized under FDA regulations.
How are Spencer Technologies’ devices classified under FDA regulations?
Spencer Technologies’ devices fall under FDA Class II classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as TCD systems and associated software.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spencertechnologies.com
- —
- —
- [email protected]
- Phone
- 206-329-7220
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 933762262
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ST3 Digital Transcrannial Doppler System | PMD150B | FDA UDI | Class II | Active |
| PMD Viewer | PMD Viewer | FDA UDI | Class II | Active |
| ST3 Digital Transcrannial Doppler System | PMD150U | FDA UDI | Class II | Active |
| Pmd Viewer | K092204 | FDA 510(k) | Class II | Active |
| Tcd 100m, Pwd13 Transducer | K002533 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Spencer Technologies has one FDA recall record initiated on February 19, 2004, which is listed with a terminated status. The recall was due to a potential discrepancy between saved blood flow velocity values and the actual velocity values displayed on the spectrogram axis.
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 |
|---|---|---|---|---|
| Feb 19, 2004 | Z-0788-04 | — | terminated | Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis. |