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FDA 510(k)

DEFINIUM 5000 X-RAY SYSTEM

K-Number: K063283 · 2006-11-17

ApplicantSedecal., Sa.
Decision Date2006-11-17
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEFINIUM 5000 X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K063283. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFINIUM 5000 X-RAY SYSTEM?

DEFINIUM 5000 X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is Sedecal., Sa.. The 510(k) number is K063283.

When did DEFINIUM 5000 X-RAY SYSTEM receive FDA 510(k) clearance?

DEFINIUM 5000 X-RAY SYSTEM received FDA 510(k) clearance on 2006-11-17, under 510(k) number K063283.

Who is the listed applicant for DEFINIUM 5000 X-RAY SYSTEM?

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

What is the FDA product code for DEFINIUM 5000 X-RAY SYSTEM?

The FDA product code for DEFINIUM 5000 X-RAY SYSTEM is MQB.

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Other records listing Sedecal., Sa. as applicant

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Related Devices (Code: MQB)

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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