Axialis Ophthalmic Ultrasound System
K-Number: K213254 · 2021-11-15
ApplicantQuantel Medical
Decision Date2021-11-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Axialis Ophthalmic Ultrasound System is a medical device manufactured by Quantel Medical. It received FDA 510(k) clearance on 2021-11-15 under approval number K213254. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Axialis Ophthalmic Ultrasound System?
Axialis Ophthalmic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Quantel Medical. The 510(k) number is K213254.
When was Axialis Ophthalmic Ultrasound System approved by the FDA?
Axialis Ophthalmic Ultrasound System received FDA 510(k) clearance on 2021-11-15, under approval number K213254.
What company makes Axialis Ophthalmic Ultrasound System?
Axialis Ophthalmic Ultrasound System is manufactured by Quantel Medical.
What is the FDA product code for Axialis Ophthalmic Ultrasound System?
The FDA product code for Axialis Ophthalmic Ultrasound System is IYO.
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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.