(154 days)
Not Found
No
The description focuses on standard image processing, visualization, and archiving functions without mentioning AI or ML.
No
The device is described as an image processing workstation software that performs viewing, manipulation, visualization, communication, and archiving of medical images. It does not exert any direct therapeutic action on a patient.
Yes
The device description directly states "The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices..." which indicates its role in diagnostics. Additionally, the predicate devices listed are diagnostic imaging workstations/processors.
No
The device is described as a software package designed to run on standard PC hardware, which can be purchased independently or supplied. While the core functionality is software-based image processing, the description explicitly mentions the reliance on and interaction with "standard PC hardware" and "standard computer components," indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The described device is an image processing workstation software that receives and manipulates medical images from CT and MRI scans. It focuses on visualization, communication, and archiving of these images.
- Lack of Specimen Analysis: The device does not analyze biological specimens. Its input is image data, not biological samples.
Therefore, while it is a medical device used in a diagnostic context, its function falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
Product codes
90 LLZ
Device Description
The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
1. Company Identification
Neo Imagery Technologies, Inc. 2315 S. Birch Log Way Hacienda Heights, CA 91745 Tel. (626) 333-3633 Fax (626) 961-0080
2. Official Correspondent
Gary J. Allsebrook Regulatory Affairs
3. Date of Submission
July 16, 1998
4. Device Name
| Classification Name: | Computed Imaging Device |
|---|---|
| Common/Usual Name: | Picture Archiving and Communications System |
| (PACS) | |
| Proprietary Name: | Neo Imagery Technologies Inc., InSight™ |
| Diagnostic Imaging Workstation |
5. Substantial Equivalence
InSight™, Diagnostic Imaging Workstation, K965179; Acculmage, AIDP (Acculmage Image Display Processor), K961023
6. Device Description and Intended Use
The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.
1
7. Software
Neo Imagery Technologies Inc. certifies that the InSight™ Diagnostic Imaging Workstation software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
8. Hazard Analysis
Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- . identification of potential hazards, their causes, and their effects;
- development of methodologies to control the occurrence of hazards and to . constrain their effects; and
- Determine any effect on patient safety and system effectiveness. .
The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
9. Safety Concerns
The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.
2
10. Substantial Equivalence
The following product provides functions, which are substantially equivalent to this product:
| Manufacturer: | Neo Imagery
Technologies | Neo Imagery
Technologies | Acculmage |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name: | InSight™ | InSight™ | AIDP |
| 510(k) Number: | | K965179 | K961023 |
| Computer Platform: | Pentium/Windows
NT | Pentium/Windows
NT | Pentium/Win95 |
| Image Format In: | Imatron Proprietary
ACR NEMA 2.0
DICOM 3.0 | Imatron Proprietary
ACR NEMA 2.0
DICOM 3.0 | Imatron Proprietary
ACR NEMA 2.0
DICOM 3.0 |
| Image Format Out: | DICOM 3.0
TIFF, BMP | DICOM 3.0
TIFF, BMP | BMP |
| Image Archive: | Magneto-Optical
Drive, 2.6 GB | Magneto-Optical
Drive, 2.6 GB | IDE Disk Drive, 1+G |
| Image Display: | Color/gray scale, CRT
or Laptop PC LCD,
up to 1024x1024, 12
bits | Color/gray scale, CRT
or Laptop PC LCD,
up to 1024x1024, 12
bits | Color/gray scale, CRT
or Laptop PC LCD,
up to 512x512, 12
bits |
| Image Processing: | Window-Level,
Zoom, Variable
smooth filter, Cine
display | Window-Level,
Zoom, Variable
smooth filter, Cine
display | Window level,
Zoom, variable Filter:
edge, sharpen,
smooth
Cine Display |
| Image Edit: | Manual
Segmentation by
drawing a contour.
Segmentation by CT
number threshold.
(MIP, MinIP,
radiographic
projection),
Surface rendering,
Quick volume
rendering,
Volume rendering | Manual
Segmentation by
drawing a contour.
Segmentation by CT
number threshold
(MIP), Surface
rendering | Manual
Segmentation by
drawing a contour.
Segmentation by CT
number( MIP,
MinIP), Surface
rendered, Depth
encoded surface,
Quick Mip |
| Volume Rendering: | Maximum, or
minimum Intensity
Projection (MIP
MinIP) Radiographic
projection, Surface
rendering, Quick
volume rendering,
Volume Rendering | Maximum Intensity
Projection(MIP),
surface rendering | Max or Min Intensity
Projection (MIP,
MinIP), Surface
Rendered Depth
encoded surface,
Quick Mip |
3
Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Tina Young CEO Neo Imagery Technologies, Inc. 2315 South Birch Log Way Hacienda Heights, CA 91745
Re: K982535
InSight™ Diagnostic Imaging Workstation Dated: November 3, 1998 Received: November 4, 1998 Regulatory class: II 21 CFR 892.2050/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 legally marketed predicate 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). You may, therefore, market the device, 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 misbranding and adulteration.
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 requirements, as set forth in the Quality System Regulation (QS) 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 the Electronic Product 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 questions on the promotion 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 notfication"(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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K982535
Neo Imagery Technologies, Inc., InSight™ Diagnostic Device Name: Imaging Workstation
Indications For Use:
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Arvil H. Calhounge of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
1
510(k) Number .
Prescription Use_ (Per 21 CFR 901.109)
Over-the-Counter Use
(Optional Format 1-2-96)