FDA 510(k)

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,

K-Number: K991455 · 1999-06-25

Decision Date1999-06-25

Product CodeEHD

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, is the device name listed in this FDA 510(k) record. The listed applicant is Trophy Radiologie. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K991455. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,?

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Trophy Radiologie. The 510(k) number is K991455.

When did ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, receive FDA 510(k) clearance?

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991455.

Who is the listed applicant for ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,?

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

What is the FDA product code for ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,?

The FDA product code for ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, is EHD.

Related Clinical Trials

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Other records listing Trophy Radiologie as applicant

K033690TROPHYPAN AND TROPHYPAN C K033419STV PRO 2 K023346TROPHYPAN K012514DIGIPAN / DPI K991912MODIFICATION TO DIGIPAN K961826DIGIPAN

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Related Devices (Code: EHD)

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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.