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

FDA 510(k)

COMPACT TOUCH Ophthalmic Ultrasound System

K-Number: K180265 · 2018-03-02

ApplicantQuantel Medical
Decision Date2018-03-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPACT TOUCH 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 2018-03-02 under 510(k) number K180265. 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 COMPACT TOUCH Ophthalmic Ultrasound System?

COMPACT TOUCH Ophthalmic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Quantel Medical. The 510(k) number is K180265.

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

COMPACT TOUCH Ophthalmic Ultrasound System received FDA 510(k) clearance on 2018-03-02, under 510(k) number K180265.

Who is the listed applicant for COMPACT TOUCH 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 COMPACT TOUCH Ophthalmic Ultrasound System?

The FDA product code for COMPACT TOUCH 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.

K251507INTEGRE LIOK232302Pocket IIIK220430CapsuloK213254Axialis Ophthalmic Ultrasound SystemK201502Vitra 810K191962Vitra 2

View all 9 devices →

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.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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.

↑