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FDA 510(k)

4D SONO-SCAN 1.0

K-Number: K110595 · 2011-04-07

ApplicantTomtec Imaging Systems GmbH
Decision Date2011-04-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4D SONO-SCAN 1.0 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 2011-04-07 under 510(k) number K110595. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4D SONO-SCAN 1.0?

4D SONO-SCAN 1.0 is a medical device that received FDA 510(k) clearance on 2011-04-07. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K110595.

When did 4D SONO-SCAN 1.0 receive FDA 510(k) clearance?

4D SONO-SCAN 1.0 received FDA 510(k) clearance on 2011-04-07, under 510(k) number K110595.

Who is the listed applicant for 4D SONO-SCAN 1.0?

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 4D SONO-SCAN 1.0?

The FDA product code for 4D SONO-SCAN 1.0 is LLZ.

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: LLZ)

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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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