K960911 · Scimage, Inc. · LMD · May 29, 1996 · Radiology
Device Facts
Record ID
K960911
Device Name
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
Applicant
Scimage, Inc.
Product Code
LMD · Radiology
Decision Date
May 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2020
Device Class
Class 1
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 windows 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.
Device Story
Netra Imaging Workstation and NetraMD software; medical image processing system for trained practitioners. Inputs: electronic image data from MRI, CT, Ultrasound, X-ray via DICOM 3.0, direct digital transfer, or video frame capture. Processing: microprocessor-controlled PC performs visualization, enhancement, 3D/4D volume reformatting (orthogonal/oblique planes), 3D reconstruction/rendering, and manual segmentation. Outputs: displayed images on workstation monitor; transmitted data to printers, archives, or DICOM-compatible equipment. Clinical use: aids diagnosis by enabling measurement of distances, areas, and volumes; facilitates communication and review of diagnostic images.
Clinical Evidence
Bench testing only. System performance evaluated against design specifications and ACR/NEMA DICOM 3.0 and ACC/ACR/NEMA (DISC95-96) standards. Results confirmed system met requirements and performed equivalently to the predicate device.
Technological Characteristics
Microprocessor-based PC; metal enclosure (7.5"x22.5"x20.5") with thermoplastic bezel; power 90-264 VAC, 47/63 Hz. Connectivity: DICOM 3.0, ACC/ACR/NEMA (DISC95-96). Software: NetraMD. Standards: DICOM 3.0, FDA 1991 Reviewer Guidance for Computer Controlled Medical Devices.
Indications for Use
Indicated for trained medical practitioners to view and manipulate MRI, CT, Ultrasound, and X-ray images as an aid in diagnosis.
Regulatory Classification
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.
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Sclmage, Inc. NETRA™ Imaging Workstation 510(k) Notification
# SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitter's Information:
Dated: March 4, 1996
Sclmage, Inc.
25500 Crescent Lane
Los Altos, California
94022-4521
Telephone: (415) 941-7484
Fax: (415) 941-7353
Contact Person: Sai P. Raya Ph.D.
President
K960911
MAY 29 1996
2. Common or Usual Name:
Medical Image Processing System
Proprietary Name: Netra™ Workstation System and Netra MD Software
Product Classification: 21 CFR § 892:750, Product Code: RA 90 LLZ
Image Processing System, Regulatory Class II
3. Predicate Device:
SCRIBE™ Medical Image Processing System
Multi-Dimensional Imaging, Inc., Newport Beach, CA
FDA 510(k) Clearance Number: K 945428
4. 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 Netra™ Medical 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.
5. Statement of intended use:
The intended use is the same as the predicate device the MDI 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:
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 windows 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.
The intended use is the same as the predicate device
SUMMARY OF SAFETY AND EFFECTIVENESS
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ATTACHMENT E
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ScImage, Inc. NETRA™ Imaging Workstation 510(k) Notification
6. Statement of technological characteristics: The ScImage, Inc. NetraMD™ Software system in 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" deep by 20.5" 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 same as 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
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ATTACHMENT E
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Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
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Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
