(191 days)
Not Found
No
The summary describes standard image processing and visualization features common in diagnostic imaging workstations, with no mention of AI, ML, or related concepts.
No
The device is described as a "Diagnostic Imaging Workstation" designed to manipulate and visualize image data to aid "in the diagnostic process," not to provide therapy.
Yes
The "Intended Use / Indications for Use" states, "The system is designed as an aide to trained medical practitioners in the diagnostic process." Additionally, the product name itself includes "Diagnostic Imaging Workstation."
No
The device description explicitly states it utilizes an "IBM compatible PC with Intel 'X'86 family microprocessors," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The InSight™ Diagnostic Imaging Workstation processes and manipulates digital images obtained from medical scanning devices (CT, MRI). It does not analyze biological samples.
- Intended Use: The intended use describes the system as an "aide to trained medical practitioners in the diagnostic process" by manipulating image data. This is consistent with medical imaging software, not an IVD.
The device is a medical imaging workstation used for processing and visualizing medical images, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The InSight™ system has the same intended use as the predicate devices. Namely, it is to aid the diagnosis of a trained medical practitioner in viewing images from CT, MRI and electronic images via image manipulation and data visualization.
The InSight™ Diagnostic Imaging Workstation must be used by or on the order of a physician. The system receives digital information from scanning devices and manipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process.
Product codes
90 LLZ
Device Description
The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archiving, characterization, and image enhancement with digital information received from medical scanning devices. System utilizes IBM compatible PC with Intel "X"86 family microprocessors and Microsoft Windows NT™ operating system for ease of maintenance and cost.
Mentions image processing
Image Processing Workstation
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI and electronic images from medical scanning devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner / physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens V.I.P.™, K893689, Virtual Imaging VIEW™ K864854/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Summary of Safety and Effectiveness
1965179
JUL - 3 1997 1. Submitter's Information: Date prepared: November 5, 1996 Neo Imagery Technologies, Inc. 2315 South Birch Log Way Hacienda Heights, CA 91745 (818) 333-3633 Fax (818) 961-0080 Contact Person: Ms. Tina Young
| 2. Proprietary Name: | InSight™ Diagnostic Imaging Workstation |
|---|---|
| Common Name: | Image Processing Workstation |
| Classification Name: | RA 90 LLZ, Image Processing System, Class II |
| 21 CFR § 892. classification unknown | |
| 3. Predicate Devices: | Siemens V.I.P.™, K893689 |
4. Device Description:
一,
ﻟﻤﺴﻠﺴﻠﺔ
The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archiving, characterization, and image enhancement with digital information received from medical scanning devices. System utilizes IBM compatible PC with Intel "X"86 family microprocessors and Microsoft Windows NT™ operating system for ease of maintenance and cost.
Virtual Imaging VIEW™ K864854/A
5. Intended Use of the Device:
The InSight™ system has the same intended use as the predicate devices. Namely, it is to aid the diagnosis of a trained medical practitioner in viewing images from CT, MRI and electronic images via image manipulation and data visualization.
6. Technological characteristics comparing to predicate devices:
The InSight™ system has no significant changes in technological characteristics from the predicate devices that will alter its safety or effectiveness. Similar to the predicate devices, the InSight™ system utilizes Intel microprocessors and Microsoft operating system to display images on a 21 inch monitor.
Although there are no performance standards established by the Special Controls: FDA on image processing workstations, Neo Imagery Technologies, Inc. has developed the InSight™ Diagnostic Imaging Workstation in compliance with the guidance issued by the FDA, CDRH, ODE such as the August 29, 1991 Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.
1
7. Substantial Equivalence:
.
The InSight™ Diagnostic Imaging Workstation has the same intended use and technological features as the predicate devices and does not raise new questions of safety and effectiveness. We believe the differences do not alter the intended diagnostic effect or affect its safety or effectiveness and therefore it is Substantially Equivalent to those predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Young C.E.O. NEO Imagery Technologies 2315 S. Birch Log Way Hacienda Heights, CA 91745
JUL - 3 1997..
Re: K965179
INSIGHT Diagnostic Imaging Workstation Dated: April 18, 1997 Received: April 18, 1997 Unclassified/Procode: 90 LLZ
Dear Ms. Young:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.D.Liau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) :
Device Name: InSight™ Diagnostic Imaging Workstation Indication For Use:
The InSight™ Diagnostic Imaging Workstation must be used by or on the order of The system receives digital information from scanning devices and a physician. manipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process. Only qualified personnel should service system hardware and software.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | (OR) | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ------ | ---------------------- | -- |
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K965179 |
|---|---|
| --------------- | --------- |