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FDA 510(k)

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH

K-Number: K030450 · 2003-05-06

ApplicantJ. Morita USA, Inc.
Decision Date2003-05-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH 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 2003-05-06 under 510(k) number K030450. 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?

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K030450.

When did 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH receive FDA 510(k) clearance?

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH received FDA 510(k) clearance on 2003-05-06, under 510(k) number K030450.

Who is the listed applicant for 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH?

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?

The FDA product code for 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH 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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