FDA 510(k)

3DI

K-Number: K113442 · 2012-02-16

Decision Date2012-02-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3DI 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 2012-02-16 under 510(k) number K113442. 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?

3DI is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Shina Systems , Ltd.. The 510(k) number is K113442.

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

3DI received FDA 510(k) clearance on 2012-02-16, under 510(k) number K113442.

Who is the listed applicant for 3DI?

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?

The FDA product code for 3DI is LLZ.

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.

K1125303DI INCLUDING CSCORE K0937033DI K070226CARDIOCT

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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.