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FDA 510(k)

3DI INCLUDING CSCORE

K-Number: K112530 · 2011-09-30

ApplicantShina Systems , Ltd.
Decision Date2011-09-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DI INCLUDING CSCORE is the device name listed in this FDA 510(k) record. The listed applicant is Shina Systems , Ltd.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K112530. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DI INCLUDING CSCORE?

3DI INCLUDING CSCORE is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Shina Systems , Ltd.. The 510(k) number is K112530.

When did 3DI INCLUDING CSCORE receive FDA 510(k) clearance?

3DI INCLUDING CSCORE received FDA 510(k) clearance on 2011-09-30, under 510(k) number K112530.

Who is the listed applicant for 3DI INCLUDING CSCORE?

The FDA 510(k) record lists Shina Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DI INCLUDING CSCORE?

The FDA product code for 3DI INCLUDING CSCORE is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Shina Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K1134423DIK0937033DIK070226CARDIOCT

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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