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FDA 510(k)

MedCAD AccuPlan System

K-Number: K223024 · 2023-03-07

ApplicantMedcad
Decision Date2023-03-07
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MedCAD AccuPlan System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K223024. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedCAD AccuPlan System?

MedCAD AccuPlan System is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Medcad. The 510(k) number is K223024.

When did MedCAD AccuPlan System receive FDA 510(k) clearance?

MedCAD AccuPlan System received FDA 510(k) clearance on 2023-03-07, under 510(k) number K223024.

Who is the listed applicant for MedCAD AccuPlan System?

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

What is the FDA product code for MedCAD AccuPlan System?

The FDA product code for MedCAD AccuPlan System is DZJ.

Other records listing Medcad 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.

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Related Devices (Code: DZJ)

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.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK220366EmbedMed3D Lifeprints UK , Ltd.

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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