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FDA 510(k)

ECHOCOM, IMAGECOM, DOKUCOM

K-Number: K001592 · 2000-06-16

ApplicantTomtec Imaging Systems GmbH
Decision Date2000-06-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOCOM, IMAGECOM, DOKUCOM 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 2000-06-16 under 510(k) number K001592. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOCOM, IMAGECOM, DOKUCOM?

ECHOCOM, IMAGECOM, DOKUCOM is a medical device that received FDA 510(k) clearance on 2000-06-16. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K001592.

When did ECHOCOM, IMAGECOM, DOKUCOM receive FDA 510(k) clearance?

ECHOCOM, IMAGECOM, DOKUCOM received FDA 510(k) clearance on 2000-06-16, under 510(k) number K001592.

Who is the listed applicant for ECHOCOM, IMAGECOM, DOKUCOM?

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 ECHOCOM, IMAGECOM, DOKUCOM?

The FDA product code for ECHOCOM, IMAGECOM, DOKUCOM is DQK.

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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: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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