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510(k) Data Aggregation
K Number
K183412Device Name
mediCAD Web
Manufacturer
mediCAD Hectec GmbH
Date Cleared
2019-10-31
(325 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
mediCAD Hectec GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
mediCAD Web is a medical browser-based software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD Web can hand over the digital plannings as DICOMs to PACS-systems.
mediCAD will also support the proper workflow necessary to effectively compare pre- and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy. The software is not for primary image interpretation. The software is not for use on mobile phones.
Device Description
mediCAD Web is a medical browser-based software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD Web can hand over the digital plannings as DICOMs to PACS-systems.
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K Number
K170702Device Name
mediCAD 4.0
Manufacturer
mediCAD Hectec Gmbh
Date Cleared
2018-09-07
(548 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
mediCAD Hectec Gmbh
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 4.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre- and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- · Orthopedics
- · Surgery and Traumatology
- · Rheumatology
- · Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- · Hip Manual Planning
- Hip Automatic Planning
- · Hip Biometry
- · Hip Intertrochanteric osteotomy
- · Hip Coxometry
- · Hip Wear Measurement
- · Hip FAI
- · Knee Prosthetic Planning
- · Biometry Planning -takes into account patient motion and metrics
- · Coxometry tracking of known measurement values in pediatrics to determine surgical intervention
- · Osteotomy determines optimum osteotomy locations
- Osteotomy by Dror Paley
- · Osteotomy (DualSide)
- · Spine
- Foot Hallux Valgus
- · Foot Ankle Joint
- · Upper Extremities
- · Biological Age Determination by Hand
- Trauma
- · Hip 3D
- · Spine 3D
Device Description
The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 4.0 can hand over the digital plannings as DICOMs to PACS-systems.
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K Number
K140434Device Name
MEDICAD CLASSIC
Manufacturer
HECTEC GMBH
Date Cleared
2014-06-05
(105 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HECTEC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Intearating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- Orthopedics .
- . Surgery and Traumatology
- Rheumatology t
- . Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- Hip Manual Planning .
- Hip Automatic Planning t
- Hip Biometry .
- . Hip - Coxometrv
- . Hip - Wear Measurement
- . Hip - FAI
- Knee Prosthetic Planning .
- Biometry Planning takes into account patient motion and metrics .
- Coxometry tracking of known measurement values in pediatrics to . determine surqical intervention
- . Osteotomy - determines optimum osteotomy locations
- . Osteotomy bv Dror Palev
- Osteotomy (DualSide)
- Spine
- Foot
- Upper Extremities
- Biological Age Determination by Hand
- Trauma
Device Description
Concentrating within the specialty of joint replacement, mediCAD 3.0 will provide an orthopedic surgeon with the ability to produce pre-surgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, mediCAD provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper presurgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
The device has been designed and manufactured to conform to the following standards: Digital Imaging and Communications in Medicine (DICOM) V3.0, ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to Computer software. ISO 14971:2007 Application of Risk Management of Medical Devices and ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
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