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Spectrum Dynamics Medical Ltd.: FDA-registered device maker in Caesarea North Ind. Park Central, Israel, 8 510(k) clearances

Name: Spectrum Dynamics Medical Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spectrum Dynamics Medical Ltd. is registered with the FDA (registration 3006209933) in Caesarea North Ind. Park Central, Israel. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 13, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006209933
Address: 22 Bareket St. North Industrial Park, Caesarea North Ind. Park Central, Israel, 3079837
Owner or operator: Spectrum Dynamics Ltd (10044347)
Roles: Manufacturer
First device listed: November 6, 2016
Registered through: 2026
Brand names listed: D-SPECT CARDIO, D-SPECT L Cardiac Scaner, D-SPECT VISTA, TruCLEAR.AI, TruCORR.AI, TruSPECT, TruSPECT.AI, VERITAS.AI and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 13, 2026	K254001	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
December 30, 2025	K253532	TruSPECT Processing Station	QIH	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
April 28, 2023	K230600	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
August 16, 2021	K212230	TruSPECT Radiological Image Processing Station	LLZ	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
July 12, 2019	K190457	VERITON CT whole body SPECT/CT system	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
November 9, 2018	K182484	VERITON CT whole body SPECT/CT system	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
April 25, 2018	K180514	VERITON NM	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov
November 4, 2016	K161740	D-SPECT Scanner, D-SPECT L Scanner	KPS	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.