K Number
K173965
Manufacturer
Date Cleared
2018-10-26

(301 days)

Product Code
Regulation Number
892.2050
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Implant Planning is a software package specifically designed and developed to enable dentists to plan and perform virtual implant surgery prior to actual surgery. Implant Planning supports surgical planning for fully or partially edentulous patient's case.

Device Description

Implant Planning is a software package specifically designed and developed to enable dentists to plan and perform virtual implant surgery prior to actual surgery.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Inteware Co. Ltd. for their "Implant Planning Software." It confirms substantial equivalence but does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the text. The document primarily focuses on the FDA's regulatory approval process and general controls, rather than the specific performance metrics and study details of the device.

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).