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FDA 510(k)

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING

K-Number: K003936 · 2001-02-14

ApplicantTomtec Imaging Systems GmbH
Decision Date2001-02-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING 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 2001-02-14 under 510(k) number K003936. 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 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING?

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K003936.

When did PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING receive FDA 510(k) clearance?

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003936.

Who is the listed applicant for PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING?

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 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING?

The FDA product code for PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING 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)

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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