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FDA 510(k)

VHF ULTRASONIC ARC-SCAN SYSTEM

K-Number: K003890 · 2001-05-22

ApplicantUltralink, LLC
Decision Date2001-05-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VHF ULTRASONIC ARC-SCAN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultralink, LLC. It received FDA 510(k) clearance on 2001-05-22 under 510(k) number K003890. 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 VHF ULTRASONIC ARC-SCAN SYSTEM?

VHF ULTRASONIC ARC-SCAN SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-22. The listed applicant is Ultralink, LLC. The 510(k) number is K003890.

When did VHF ULTRASONIC ARC-SCAN SYSTEM receive FDA 510(k) clearance?

VHF ULTRASONIC ARC-SCAN SYSTEM received FDA 510(k) clearance on 2001-05-22, under 510(k) number K003890.

Who is the listed applicant for VHF ULTRASONIC ARC-SCAN SYSTEM?

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

What is the FDA product code for VHF ULTRASONIC ARC-SCAN SYSTEM?

The FDA product code for VHF ULTRASONIC ARC-SCAN SYSTEM is IYO.

Related Clinical Trials

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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Other records listing Ultralink, LLC 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.

K021333ARTEMIS

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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