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FDA 510(k)

LOGIQ S8

K-Number: K170445 · 2017-04-11

ApplicantGE Healthcare
Decision Date2017-04-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ S8 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K170445. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOGIQ S8?

LOGIQ S8 is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is GE Healthcare. The 510(k) number is K170445.

When did LOGIQ S8 receive FDA 510(k) clearance?

LOGIQ S8 received FDA 510(k) clearance on 2017-04-11, under 510(k) number K170445.

Who is the listed applicant for LOGIQ S8?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ S8?

The FDA product code for LOGIQ S8 is IYN.

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.

Other records listing GE Healthcare 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.

View all 58 devices →

Related Devices (Code: IYN)

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.

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.