Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADAS 3D

K-Number: K212421 · 2021-09-03

ApplicantAdas3D Medical S.L.
Decision Date2021-09-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADAS 3D is a medical device manufactured by Adas3D Medical S.L.. It received FDA 510(k) clearance on 2021-09-03 under approval number K212421. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAS 3D?

ADAS 3D is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Adas3D Medical S.L.. The 510(k) number is K212421.

When was ADAS 3D approved by the FDA?

ADAS 3D received FDA 510(k) clearance on 2021-09-03, under approval number K212421.

What company makes ADAS 3D?

ADAS 3D is manufactured by Adas3D Medical S.L..

What is the FDA product code for ADAS 3D?

The FDA product code for ADAS 3D is LLZ.

Other Devices by Adas3D Medical S.L.

K210850ADAS 3D K230803ADAS 3D K240791ADAS 3D

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑