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FDA 510(k)

IMAGYS

K-Number: K102000 · 2010-10-12

ApplicantKeosys Sas
Decision Date2010-10-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGYS is the device name listed in this FDA 510(k) record. The listed applicant is Keosys Sas. It received FDA 510(k) clearance on 2010-10-12 under 510(k) number K102000. 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 IMAGYS?

IMAGYS is a medical device that received FDA 510(k) clearance on 2010-10-12. The listed applicant is Keosys Sas. The 510(k) number is K102000.

When did IMAGYS receive FDA 510(k) clearance?

IMAGYS received FDA 510(k) clearance on 2010-10-12, under 510(k) number K102000.

Who is the listed applicant for IMAGYS?

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

What is the FDA product code for IMAGYS?

The FDA product code for IMAGYS is LLZ.

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Other records listing Keosys Sas 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.

K160334Advanced Medical Imaging Software Suite (KSWVWR)K070606VISIO+CD VIEWER# KPSCDVE01

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

View on FDA Database →

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

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