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FDA 510(k)

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

K-Number: K020561 · 2002-05-09

ApplicantTomtec Imaging Systems GmbH
Decision Date2002-05-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems GmbH. It received FDA 510(k) clearance on 2002-05-09 under 510(k) number K020561. 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 SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN?

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN is a medical device that received FDA 510(k) clearance on 2002-05-09. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K020561.

When did SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN receive FDA 510(k) clearance?

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN received FDA 510(k) clearance on 2002-05-09, under 510(k) number K020561.

Who is the listed applicant for SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN?

The FDA 510(k) record lists Tomtec Imaging Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN?

The FDA product code for SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN is IYO.

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Other records listing Tomtec Imaging Systems GmbH 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.

K213544TOMTEC-ARENAK201632TOMTEC-ARENAK132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENAK122289IMAGE-COM 5.0K1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.0K1107464D LV-ANALYSIS 3.0

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Related Devices (Code: 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.

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