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FDA 510(k)

EXPLOR-X 70

K-Number: K991310 · 1999-06-18

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date1999-06-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXPLOR-X 70 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 1999-06-18 under 510(k) number K991310. 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 EXPLOR-X 70?

EXPLOR-X 70 is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K991310.

When did EXPLOR-X 70 receive FDA 510(k) clearance?

EXPLOR-X 70 received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991310.

Who is the listed applicant for EXPLOR-X 70?

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 EXPLOR-X 70?

The FDA product code for EXPLOR-X 70 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)K130109ENDOGRAPH DCK111152ROTOGRAPH EVO 3DK090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191K080859DRF 4343

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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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