FDA 510(k)

IRIS-XP

K-Number: K212412 · 2021-09-13

Decision Date2021-09-13

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

IRIS-XP is the device name listed in this FDA 510(k) record. The listed applicant is Medicore Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K212412. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS-XP?

IRIS-XP is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K212412.

When did IRIS-XP receive FDA 510(k) clearance?

IRIS-XP received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212412.

Who is the listed applicant for IRIS-XP?

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

What is the FDA product code for IRIS-XP?

The FDA product code for IRIS-XP is LHQ.

Related Devices (Code: LHQ)

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.

K253911Derma-2Neko Health AB K232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private Limited K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health

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.