INSIGHT DIAGNOSTIC IMAGING WORKSTATION

K982535 · Neo Imagery Technologies, Inc. · LLZ · Dec 21, 1998 · Radiology

Device Facts

• Record ID: K982535
• Device Name: INSIGHT DIAGNOSTIC IMAGING WORKSTATION
• Applicant: Neo Imagery Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

InSight™ Diagnostic Imaging Workstation is a software package running on standard off-the-shelf PC hardware (Pentium/Windows NT). It receives medical image files (CT, MRI) via DICOM 3.0, ACR NEMA 2.0, or proprietary formats. The device performs real-time viewing, image manipulation (window-level, zoom, smooth filters, cine display), and 3D/4D visualization (MIP, MinIP, surface/volume rendering). It supports manual segmentation via contour drawing or CT number thresholding. Outputs are displayed on CRT or LCD monitors and archived to magneto-optical drives. Used by clinicians for diagnostic imaging workflows; facilitates clinical decision-making through enhanced visualization and manipulation of scan data.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based workstation running on standard Pentium PC hardware with Windows NT OS. Supports DICOM 3.0, ACR NEMA 2.0, and proprietary image formats. Display resolution up to 1024x1024, 12-bit. Storage via 2.6 GB Magneto-Optical drive. Processing includes window-leveling, filtering, and volume rendering algorithms. Minor level of concern for software safety.

Indications for Use

Indicated for use as an image processing workstation for viewing, manipulating, visualizing (3D/4D), communicating, and archiving medical images (CT/MRI) in a clinical setting.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• InSight™ Diagnostic Imaging Workstation (K965179)
• Acculmage AIDP (Acculmage Image Display Processor) (K961023)

Submission Summary (Full Text)

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## 1. Company Identification

Neo Imagery Technologies, Inc. 2315 S. Birch Log Way Hacienda Heights, CA 91745 Tel. [phone] Fax [phone]

# 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<br>(PACS) |
| Proprietary Name: | Neo Imagery Technologies Inc., InSight™<br>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.

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# 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.

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# 10. Substantial Equivalence

The following product provides functions, which are substantially equivalent to this product:

| Manufacturer: | Neo Imagery<br>Technologies | Neo Imagery<br>Technologies | Acculmage |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name: | InSight™ | InSight™ | AIDP |
| 510(k) Number: | | K965179 | K961023 |
| Computer Platform: | Pentium/Windows<br>NT | Pentium/Windows<br>NT | Pentium/Win95 |
| Image Format In: | Imatron Proprietary<br>ACR NEMA 2.0<br>DICOM 3.0 | Imatron Proprietary<br>ACR NEMA 2.0<br>DICOM 3.0 | Imatron Proprietary<br>ACR NEMA 2.0<br>DICOM 3.0 |
| Image Format Out: | DICOM 3.0<br>TIFF, BMP | DICOM 3.0<br>TIFF, BMP | BMP |
| Image Archive: | Magneto-Optical<br>Drive, 2.6 GB | Magneto-Optical<br>Drive, 2.6 GB | IDE Disk Drive, 1+G |
| Image Display: | Color/gray scale, CRT<br>or Laptop PC LCD,<br>up to 1024x1024, 12<br>bits | Color/gray scale, CRT<br>or Laptop PC LCD,<br>up to 1024x1024, 12<br>bits | Color/gray scale, CRT<br>or Laptop PC LCD,<br>up to 512x512, 12<br>bits |
| Image Processing: | Window-Level,<br>Zoom, Variable<br>smooth filter, Cine<br>display | Window-Level,<br>Zoom, Variable<br>smooth filter, Cine<br>display | Window level,<br>Zoom, variable Filter:<br>edge, sharpen,<br>smooth<br>Cine Display |
| Image Edit: | Manual<br>Segmentation by<br>drawing a contour.<br>Segmentation by CT<br>number threshold.<br>(MIP, MinIP,<br>radiographic<br>projection),<br>Surface rendering,<br>Quick volume<br>rendering,<br>Volume rendering | Manual<br>Segmentation by<br>drawing a contour.<br>Segmentation by CT<br>number threshold<br>(MIP), Surface<br>rendering | Manual<br>Segmentation by<br>drawing a contour.<br>Segmentation by CT<br>number( MIP,<br>MinIP), Surface<br>rendered, Depth<br>encoded surface,<br>Quick Mip |
| Volume Rendering: | Maximum, or<br>minimum Intensity<br>Projection (MIP<br>MinIP) Radiographic<br>projection, Surface<br>rendering, Quick<br>volume rendering,<br>Volume Rendering | Maximum Intensity<br>Projection(MIP),<br>surface rendering | Max or Min Intensity<br>Projection (MIP,<br>MinIP), Surface<br>Rendered Depth<br>encoded surface,<br>Quick Mip |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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

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510(k) Number .

Prescription Use_ (Per 21 CFR 901.109)

Over-the-Counter Use

(Optional Format 1-2-96)