Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Exo Iris

K-Number: K211527 · 2021-08-20

ApplicantExo Imaging, Inc.
Decision Date2021-08-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Exo Iris is a medical device manufactured by Exo Imaging, Inc.. It received FDA 510(k) clearance on 2021-08-20 under approval number K211527. 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 Exo Iris?

Exo Iris is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Exo Imaging, Inc.. The 510(k) number is K211527.

When was Exo Iris approved by the FDA?

Exo Iris received FDA 510(k) clearance on 2021-08-20, under approval number K211527.

What company makes Exo Iris?

Exo Iris is manufactured by Exo Imaging, Inc..

What is the FDA product code for Exo Iris?

The FDA product code for Exo Iris is IYN.

Other Devices by Exo Imaging, Inc.

K222198Exo Iris (El2001)

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.

↑