Spectrum Dynamics, Ltd.
Kfar Saba, IL
Spectrum Dynamics , Ltd. appears in FDA device records in Kfar Saba, IL. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Spectrum Dynamics, Ltd. between 2006 and 2016. The busiest year on record is 2006, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160120 | D-SPECT Processing and Reviewing Workstation | KPS | Substantially Equivalent | |
| K072468 | MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM | KPS | Substantially Equivalent | |
| K062450 | D-SPECT CARDIAC SCANNER SYSTEM | KPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1214-2012 | D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033, Caesarea, 30889 Israel D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV. | 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 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain