Shina Systems Ltd.

CAESAREA, 3079504 Haifa, IL

SHINA SYSTEMS LTD. appears in FDA device records in CAESAREA, 3079504 Haifa, IL. FDA records list 4 510(k) clearances between 2007-03-09 and 2012-02-16, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for Shina Systems Ltd. between 2007 and 2012. The busiest year on record is 2007, with 1. The most recent is 2012, with 1.

Clearances by year, as a table

510(k) clearance decisions for Shina Systems Ltd., by decision year
Year	Clearances
2007	1
2010	1
2011	1
2012	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K113442	3DI	LLZ	Substantially Equivalent	2012-02-16
K112530	3DI INCLUDING CSCORE	LLZ	Substantially Equivalent	2011-09-30
K093703	3DI	LLZ	Substantially Equivalent	2010-01-19
K070226	CARDIOCT	LLZ	Substantially Equivalent	2007-03-09

Registered establishments

FDA registered establishments for Shina Systems Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3006551230	3006551230	SHINA SYSTEMS LTD.	7 Haeshel ST. P.O.Box 3072,, CAESAREA, 3079504 Haifa 3079504 IL	2026	LLZ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

LLZSystem, Image Processing, Radiological

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain