(84 days)
K 945428
Not Found
No
The document describes standard image processing and communication functionalities, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is intended for viewing and manipulation of medical images as an aid in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" states that the system is intended for "viewing and manipulation of high quality MRI, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner." This explicitly indicates its role in aiding diagnosis.
No
The device description explicitly mentions "microprocessor PC computer controlled solid state digital data and video receiving and transmission electronics and accessories," indicating hardware components are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "viewing and manipulation of high quality MRI, CT, Ultrasound and X-ray electronic images as an aid in diagnosis". This involves processing and displaying medical images obtained from imaging modalities, not analyzing biological samples (like blood, urine, tissue) outside the body.
- Device Description: The description focuses on receiving, manipulating, and communicating digital image data. It describes a "Medical Image Processing System and digital image communications system". This aligns with image analysis and display, not in vitro testing.
- Input Imaging Modality: The input modalities are MRI, CT, Ultrasound, and X-ray. These are imaging techniques that capture images of the body, not methods for analyzing biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is centered around processing and displaying medical images, which falls under the category of medical image processing or PACS (Picture Archiving and Communication System) type devices.
N/A
Intended Use / Indications for Use
The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRI, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner.
The NetraMD™ Software system in conjunction with NETRA™ Imaging Workstation system is used for:
1.) receiving and storing of image data from a ACR/NEMA DICOM 3.0 compatible medical imaging scanning device, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology (DISC95-96) storage media, direct digital transfer from a medical imaging scanning device and video frame capture from a medical imaging scanning device.
2.) displaying and reviewing received images in individual image with window/level and panning/zooming controls, reformatting of 3D and 4D volumes in orthogonal and oblique planes, volumetric presentation of 3D and 4D volumes using 3D reconstruction and rendering, measurement of distances, areas and volumes, and manual segmentation of structures of interest for 3D presentation.
3.) sending image data to ACR/NEMA DICOM 3.0 compatible equipment, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology storage media, printer, scanning device monitor, independent monitor or other device for purpose of communication, archiving, review and display of medical diagnostic images.
Product codes
RA 90 LLZ
Device Description
The Netra™ Workstation System and NetraMD™ Software is a Medical Image Processing System and digital image communications system for use by the trained medical practitioner. The Netra™ Image Processing System receives electronic information from medical imaging devices and manipulates that data for purposes of visualization, communication, archiving, characterization, comparison to other images and image enhancement.
It is similar in design to other such digital image communications system devices. It has microprocessor PC computer controlled solid state digital data and video receiving and transmission electronics and accessories. It has a microprocessor PC computer controlled solid state digital data and video receiving storage and transmission electronics and accessories. It is housed in a metal 7.5" wide by 22.5" high enclosure with formed thermoplastic front bezel. It's power source is selectable 47/63 Hz, 90 to 264 VAC.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, Ultrasound, X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted by testing the system to the ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) Standard, Version 3.0, and ACC/NEMA DICOM 3.0 Digital Interchange for Standard for Cardiology (DISC95-96), and to the Netra™ design specifications. A DICOM 3.0 Conformance Statement is provided in the submission. The performance evaluations indicated that the system met the standard's and requirements, consistently performed within its design parameters, and equivalently to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 945428
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
| 1. | Submitter's Information: | Dated: March 4, 1996
ScImage, Inc.
25500 Crescent Lane
Los Altos, California
94022-4521
Telephone: (415) 941-7484
Fax: (415) 941-7353 | K960911
MAY 29 1996 |
|----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Contact Person: | Sai P. Raya Ph.D.
President | |
| 2. | Common or Usual Name: | Medical Image Processing System | |
| | Proprietary Name: | Netra TM Workstation System and Netra MD Software | |
| | Product Classification: | 21 CFR § 892.1750, Product Code: RA 90 LLZ
Image Processing System, Regulatory Class II | |
| 3. | Predicate Device: | SCRIBE TM Medical Image Processing System
Multi-Dimensional Imaging, Inc., Newport Beach, CA
FDA 510(k) Clearance Number: K 945428 | |
SUMMARY OF SAFETY AND EFFECTIVENESS
- Description of Device:
The Netra™ Workstation System and NetraMD™ Software is a Medical Image Processing System and digital image communications system for use by the trained medical practitioner. The Netral Image Processing System receives electronic information from medical imaging devices and manipulates that data for purposes of visualization, communication, archiving, characterization, comparison to other images and image enhancement.
It is similar in design to other such digital image communications system devices. It has microprocessor PC computer controlled solid state digital data and video receiving and transmission electronics and accessories.
The intended use is the same as the predicate device the MDI ડ. Statement of intended use: SCRIBE™ workstation. The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRI, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner.
The NetraMD™ Software system in conjunction with NETRA™ Imaging Workstation system is used for:
-
- ) receiving and storing of image data from a ACR/NEMA DICOM 3.0 compatible medical imaging scanning device, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology (DISC95-96) storage media, direct digital transfer from a medical imaging scanning device and video frame capture from a medical imaging scanning device .
-
- ) displaying and reviewing received images in individual image with window/level and panning/zooming controls, reformatting of 3D and 4D volumes in orthogonal and oblique planes, volumetric presentation of 3D and 4D volumes using 3D reconstruction and rendering, measurement of distances, areas and volumes, and manual segmentation of structures of interest for 3D presentation.
-
- ) sending image data to ACR/NEMA DICOM 3.0 compatible equipment, ACC/ACR/NEMA (DICOM 3.0) Digital Interchange Standard for Cardiology storage media, printer, scanning device monitor, independent monitor or other device for purpose of communication, archiving, review and display of medical diagnostic images.
The intended use is the same as the predicate device SUMMARY OF SAFETY AND EFFECTIVENESS page 1 of 2
1
K, 609.1 Pi 2 of 2
NETRA™ Imaging Workstation 510(k) Notification Scimage, Inc.
Statement of technological characteristics: The Sclmage. Inc. NetraMD™ Software system in 6. conjunction with NETRA™ Imaging Workstation system has no significant change in design, materials, energy source or other technological characteristics when compared to the predicate device. It has a microprocessor PC computer controlled solid state digital data and video receiving storage and transmission electronics and accessories. It is housed in a metal 7.5" wide by 22.5" high enclosure with formed thermoplastic front bezel. It's power source is selectable 47/63 Hz, 90 to 264 VAC.
There are only minor configuration differences between the NetraMD™ Software and NETRA™ Imaging Workstation system and the MDI SCRIBE™ Workstation predicate device. These minor differences do not alter the intended use or affect the safety and effectiveness of the NetraMD™ Software and NETRA™ Imaging Workstation system when used as labeled.
The intended use and the technological characteristics are the predicate device and therefore we believe it is substantially equivalent to it.
Special Controls: Although there are no performance standards established by the FDA for these devices, the NetraMD™ Software and NETRA™ Imaging Workstation system has been designed, and manufactured to meet the following standards:
- ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) Standard, Version 3.0. A Conformance Statement is provided.
- ACC/NEMA DICOM 3.0 Digital Interchange for Standard for Cardiology (DISC95-96)
The device and its development process also comply with the FDA, CDRH, ODE, August 29, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.
Performance tests were conducted by testing the system to the above standards and to the Netra™ design specifications. A DICOM 3.0 Conformance Statement is provided in the submission.
The performance evaluations indicated that the system met the standard's and requirements, consistently performed within its design parameters, and equivalently to the predicate device.
This data is summarized in the submission, and supports the safety and efficacy of the NetraMD™ Software and NETRA™ Imaging Workstation system.
SUMMARY OF SAFETY AND EFFECTIVENESS page 2 of 2