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FDA 510(k)

MAYFIELD SCANMATE MOBILE CT SYSTEM

K-Number: K053210 · 2006-01-06

ApplicantSchaerer Mayfield USA, Inc.
Decision Date2006-01-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAYFIELD SCANMATE MOBILE CT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Schaerer Mayfield USA, Inc.. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K053210. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD SCANMATE MOBILE CT SYSTEM?

MAYFIELD SCANMATE MOBILE CT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Schaerer Mayfield USA, Inc.. The 510(k) number is K053210.

When did MAYFIELD SCANMATE MOBILE CT SYSTEM receive FDA 510(k) clearance?

MAYFIELD SCANMATE MOBILE CT SYSTEM received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053210.

Who is the listed applicant for MAYFIELD SCANMATE MOBILE CT SYSTEM?

The FDA 510(k) record lists Schaerer Mayfield USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAYFIELD SCANMATE MOBILE CT SYSTEM?

The FDA product code for MAYFIELD SCANMATE MOBILE CT SYSTEM is JAK.

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Other records listing Schaerer Mayfield USA, Inc. 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.

K041897MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01

Related Devices (Code: JAK)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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