DigiGuide System
by Protomed, Inc. 510(k)
Active
510(k) K193499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193499 | Date4 Nov 2020 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4120
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The DigiGuide System is a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. It processes input data files to produce output data files used as input to a rapid prototyping portion of the system that generates physical outputs.
The system consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models to plan and implement maxillofacial surgery. It is supplied as a software system for use in dental and maxillofacial surgical planning, with authorization under FDA 510(k) clearance K193499, product code DZJ, and classification as a Class II device.
Other devices from Proto-Med, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the DigiGuide System used for?
The DigiGuide System is a software system and image segmentation system that processes input data files from medical scanners such as CT-based systems to produce output data files used as input to a rapid prototyping portion of the system that generates physical outputs. It consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models to plan and implement maxillofacial surgery. It is supplied as a software system for use in dental and maxillofacial surgical planning.
How is the DigiGuide System supplied and what does it include?
The DigiGuide System is supplied as a software system for use in dental and maxillofacial surgical planning. It consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models to plan and implement maxillofacial surgery. The system processes input data files from medical scanners such as CT-based systems to produce output data files used as input to a rapid prototyping portion of the system that generates physical outputs.
What regulatory pathway was used for the DigiGuide System and what is its classification?
The DigiGuide System received authorization under FDA 510(k) clearance K193499, with product code DZJ, and is classified as a Class II device. The clearance type is Traditional, and the decision description indicates it was found Substantially Equivalent (SESE) to a predicate device. The device was reviewed by the Dental advisory committee (DE).