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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2021-11-15 under 510(k) 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. The listed applicant is Quantel Medical. The 510(k) number is K213254.

When did Axialis Ophthalmic Ultrasound System receive FDA 510(k) clearance?

Axialis Ophthalmic Ultrasound System received FDA 510(k) clearance on 2021-11-15, under 510(k) number K213254.

Who is the listed applicant for Axialis Ophthalmic Ultrasound System?

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

What is the FDA product code for Axialis Ophthalmic Ultrasound System?

The FDA product code for Axialis Ophthalmic Ultrasound System is IYO.

Other records listing Quantel Medical 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.

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Related Devices (Code: IYO)

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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