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FDA 510(k)

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17

K-Number: K073695 · 2008-04-09

ApplicantJ. Morita USA, Inc.
Decision Date2008-04-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2008-04-09 under 510(k) number K073695. 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 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17?

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 is a medical device that received FDA 510(k) clearance on 2008-04-09. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K073695.

When did 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 receive FDA 510(k) clearance?

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 received FDA 510(k) clearance on 2008-04-09, under 510(k) number K073695.

Who is the listed applicant for 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17?

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

What is the FDA product code for 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17?

The FDA product code for 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 is JAK.

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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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