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FDA 510(k)

3D Bolus Software

K-Number: K180289 · 2018-07-10

Applicant3D Bolus, Inc.
Decision Date2018-07-10
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Bolus Software is the device name listed in this FDA 510(k) record. The listed applicant is 3D Bolus, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180289. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D Bolus Software?

3D Bolus Software is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is 3D Bolus, Inc.. The 510(k) number is K180289.

When did 3D Bolus Software receive FDA 510(k) clearance?

3D Bolus Software received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180289.

Who is the listed applicant for 3D Bolus Software?

The FDA 510(k) record lists 3D Bolus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Bolus Software?

The FDA product code for 3D Bolus Software is MUJ.

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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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