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FDA 510(k)

DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO

K-Number: K100317 · 2010-03-24

ApplicantVATECH Co., Ltd.
Decision Date2010-03-24
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2010-03-24 under 510(k) number K100317. 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 DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO?

DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K100317.

When did DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO receive FDA 510(k) clearance?

DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO received FDA 510(k) clearance on 2010-03-24, under 510(k) number K100317.

Who is the listed applicant for DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO?

The FDA 510(k) record lists VATECH Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO?

The FDA product code for DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO is MUH.

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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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