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FDA 510(k)

ENDOGRAPH DC

K-Number: K130109 · 2013-08-01

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2013-08-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOGRAPH DC is the device name listed in this FDA 510(k) record. The listed applicant is Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2013-08-01 under 510(k) number K130109. 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 ENDOGRAPH DC?

ENDOGRAPH DC is a medical device that received FDA 510(k) clearance on 2013-08-01. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K130109.

When did ENDOGRAPH DC receive FDA 510(k) clearance?

ENDOGRAPH DC received FDA 510(k) clearance on 2013-08-01, under 510(k) number K130109.

Who is the listed applicant for ENDOGRAPH DC?

The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOGRAPH DC?

The FDA product code for ENDOGRAPH DC is EHD.

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Other records listing Villa Sistemi Medicali S.P.A. 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.

K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)K111152ROTOGRAPH EVO 3DK090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191K080859DRF 4343K050190APOLLO

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Related Devices (Code: EHD)

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.

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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.

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