Spencer Technologies
Country not established
Spencer Technologies is a medical device manufacturer, with 5 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 1 FDA recall as of 15 Nov 2026.
- Devices
- 5
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 3
- FDA 510(k) 2
- Device classes
- FDA Class II 5
- FDA recalls
- Identifiers
- DUNS 933762262
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Pmd Viewer Ref K092204
Regimes: 510(k) Registry: 510(k)Tcd 100M, PWD13 Transducer Ref K002533
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 933762262
- Phone
- 206-329-7220
FDA recalls
FDA recall records list 1 recall initiated by Spencer Technologies, initiated on 2004-02-19. By recorded status: 1 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.
2004
- 19 Feb 2004 Z-0788-04 Unclassified (pre-2012) Terminated Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
Full distribution text
- 19 Feb 2004 Z-0788-04 Unclassified (pre-2012) Terminated Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
Frequently asked questions
How many devices does Spencer Technologies have in the registry?
The registry currently lists 5 devices for Spencer Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spencer Technologies's devices?
Among its 5 most recently registered devices, Spencer Technologies has devices listed in FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Spencer Technologies's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Spencer Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spencer Technologies?
FDA recall records list 1 recall initiated by Spencer Technologies, the most recent initiated on 19 Feb 2004. 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 Spencer Technologies in the registry?
The most recently registered devices listed for Spencer Technologies include ST3 Digital Transcrannial Doppler System PMD150B, PMD Viewer, ST3 Digital Transcrannial Doppler System PMD150U and TCD 100M, PWD13 TRANSDUCER.