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FDA 510(k)

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM

K-Number: K071403 · 2007-06-11

ApplicantImaging Dynamics Company , Ltd.
Decision Date2007-06-11
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2007-06-11 under 510(k) number K071403. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM?

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K071403.

When did X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM received FDA 510(k) clearance on 2007-06-11, under 510(k) number K071403.

Who is the listed applicant for X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM?

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

What is the FDA product code for X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM?

The FDA product code for X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM is KPR.

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Other records listing Imaging Dynamics Company , Ltd. as applicant

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K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCIK171169Aquarius 8600 1417TG and Aquarius 8600 1717TGK171175Aquarius 8600 1417WCK170202Aquarius 8600K111098INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLANK071401X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

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Related Devices (Code: KPR)

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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