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FDA 510(k)

MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE

K-Number: K003672 · 2001-02-22

ApplicantMedge Platforms, Inc.
Decision Date2001-02-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Medge Platforms, Inc.. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K003672. 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 MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE?

MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Medge Platforms, Inc.. The 510(k) number is K003672.

When did MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE receive FDA 510(k) clearance?

MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE received FDA 510(k) clearance on 2001-02-22, under 510(k) number K003672.

Who is the listed applicant for MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE?

The FDA 510(k) record lists Medge Platforms, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE?

The FDA product code for MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE is IYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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