Identifiers
- 510(k) Number
- K192282 FDA 510(k)
- FDA Product Code
- DZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AccuPlan System is a software and image segmentation system designed for the transfer of imaging information from medical scanners, such as CT-based systems. It processes input data files to generate output data files that can be used as digital models or as input for rapid prototyping.
This system is intended for use in patient-specific surgical planning for maxillofacial, orthognathic, and cranial procedures. It has received FDA 510(k) clearance under the regulation number 872.4120.
Frequently asked questions
What is the primary purpose of the MedCAD AccuPlan System?
The system is designed for patient-specific surgical planning. It functions by transferring and processing imaging information from medical scanners, such as CT-based systems, to create digital models or input files for rapid prototyping for maxillofacial, orthognathic, and cranial procedures.
Has the AccuPlan System received regulatory authorization?
Yes, the MedCAD AccuPlan System has received FDA 510(k) clearance. It is classified under regulation number 872.4120, which pertains to dental devices.
How does the system handle medical imaging data?
The software performs image segmentation to process input data files derived from medical scanners. It then converts this information into output data files that clinicians can utilize as digital models or for rapid prototyping during the surgical planning process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Patient-Specific Surgical Planning - AccuPlan® by MedCAD, AccuPlan® & AccuPlate® for CMF Reconstruction - MedCAD, PDF MedCAD AccuPlan System Coding Reference Guide - Zimmer Biomet, MedCAD® AccuPlan® System (K192282) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192282 | Class II | Active |
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Manufacturer
- Manufacturer
- Medcad
Sources (1)
- FDA 510(k) K192282 24 fields · synced Sep 21, 2026