Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221943Device Name
EmbedMed
Manufacturer
3D LifePrints UK Ltd.
Date Cleared
2023-02-01
(211 days)
Product Code
PBF
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
3D LifePrints UK Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K220366Device Name
EmbedMed
Manufacturer
3D LifePrints UK Ltd.
Date Cleared
2022-09-30
(234 days)
Product Code
DZJ, LLZ
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
3D LifePrints UK Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Device Description
EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures. Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).
Ask a Question
Page 1 of 1