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FDA 510(k)

DIGIPAN / DPI

K-Number: K012514 · 2001-12-21

ApplicantTrophy Radiologie
Decision Date2001-12-21
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGIPAN / DPI is the device name listed in this FDA 510(k) record. The listed applicant is Trophy Radiologie. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K012514. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIPAN / DPI?

DIGIPAN / DPI is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Trophy Radiologie. The 510(k) number is K012514.

When did DIGIPAN / DPI receive FDA 510(k) clearance?

DIGIPAN / DPI received FDA 510(k) clearance on 2001-12-21, under 510(k) number K012514.

Who is the listed applicant for DIGIPAN / DPI?

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 DIGIPAN / DPI?

The FDA product code for DIGIPAN / DPI is MUH.

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Other records listing Trophy Radiologie 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.

K033690TROPHYPAN AND TROPHYPAN CK033419STV PRO 2K023346TROPHYPANK991455ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,K991912MODIFICATION TO DIGIPANK961826DIGIPAN

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Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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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