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FDA 510(k)

DASI Dimensions (V1.0)

K-Number: K231324 · 2024-01-08

ApplicantDasi Simulations
Decision Date2024-01-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DASI Dimensions (V1.0) is a medical device manufactured by Dasi Simulations. It received FDA 510(k) clearance on 2024-01-08 under approval number K231324. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DASI Dimensions (V1.0)?

DASI Dimensions (V1.0) is a medical device that received FDA 510(k) clearance on 2024-01-08. It is manufactured by Dasi Simulations. The 510(k) number is K231324.

When was DASI Dimensions (V1.0) approved by the FDA?

DASI Dimensions (V1.0) received FDA 510(k) clearance on 2024-01-08, under approval number K231324.

What company makes DASI Dimensions (V1.0)?

DASI Dimensions (V1.0) is manufactured by Dasi Simulations.

What is the FDA product code for DASI Dimensions (V1.0)?

The FDA product code for DASI Dimensions (V1.0) is QIH.

Other Devices by Dasi Simulations

K223809PrecisionTAVI (v1.1)

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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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