Spectrum Dynamics, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Spectrum Dynamics, Ltd. makes
Spectrum Dynamics, Ltd. manufactures the D-SPECT Cardiac Scanner System, a device designed for cardiac imaging, along with its associated modifications and a dedicated workstation for processing and reviewing imaging data.
The company’s portfolio is regulated under Class II devices in the US and includes products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
D-Spect Cardiac Scanner System Ref K062450
Regimes: 510(k) Registry: 510(k)Modification To D-Spect Cardiac Scanner System Ref K072468
Regimes: 510(k) Registry: 510(k)D-SPECT Processing and Reviewing Workstation Ref K160120
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Spectrum Dynamics, Ltd., initiated on 2011-07-15. 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.
2011
- 15 Jul 2011 Z-1214-2012 Unclassified (pre-2012) Terminated The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically, it was reported that if the detector housing securing mechanism is compromised, the detector housing may pull away from its secured position on the gantry and potentially come into contact with a patient. The reported event was discovered during set up and thus did not involve a patient or p
Frequently asked questions
How many devices does Spectrum Dynamics, Ltd. have in the registry?
The registry currently lists 3 devices for Spectrum Dynamics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrum Dynamics, Ltd.'s devices?
Among its 3 most recently registered devices, Spectrum Dynamics, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spectrum Dynamics, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spectrum Dynamics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spectrum Dynamics, Ltd.?
FDA recall records list 1 recall initiated by Spectrum Dynamics, Ltd., the most recent initiated on 15 Jul 2011. 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 Spectrum Dynamics, Ltd. in the registry?
The most recently registered devices listed for Spectrum Dynamics, Ltd. include D-SPECT CARDIAC SCANNER SYSTEM, MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM and D-SPECT Processing and Reviewing Workstation.