FDA 510(k)

DASI Dimensions (V1.0)

K-Number: K231324 · 2024-01-08

Decision Date2024-01-08

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DASI Dimensions (V1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Dasi Simulations. It received FDA 510(k) clearance on 2024-01-08 under 510(k) 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. The listed applicant is Dasi Simulations. The 510(k) number is K231324.

When did DASI Dimensions (V1.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for DASI Dimensions (V1.0)?

The FDA 510(k) record lists Dasi Simulations as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Dasi Simulations 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.

K223809PrecisionTAVI (v1.1)

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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.