ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP

K990241 · Accuimage Diagnostics Corp. · LLZ · Sep 23, 1999 · Radiology

Device Facts

• Record ID: K990241
• Device Name: ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
• Applicant: Accuimage Diagnostics Corp.
• Product Code: LLZ · Radiology
• Decision Date: Sep 23, 1999
• 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-shell" and may be purchased independently by the end user or from AccuImage. The AccuImage, AccuView 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

AccuView is a diagnostic imaging workstation software package running on standard PC hardware (Windows 95/98/NT). It receives medical image files (CT, MRI) via DICOM 3.0, ACR NEMA 2.0, or proprietary formats. The software performs real-time image processing, including window/level, pan, zoom, filtering, and cine display. Plug-ins provide advanced functionality: AccuScore (3D calcium scoring using volumetric Agatston algorithm), AccuAnalyze, AccuShade, AccuVRT, and AccuMIP (volume/surface rendering). AccuScope enables virtual endoscopy (fly-through of anatomic cavities) with auto-flight path calculation and collision detection. Used by clinicians in clinical settings to visualize and analyze patient anatomy. Output includes processed images, 3D/4D reconstructions, and calcium scoring reports. These outputs assist clinicians in diagnostic decision-making and patient assessment.

Clinical Evidence

Bench testing only. No clinical data provided. The device was validated through design, coding, and testing phases, including hazard analysis, to ensure safety and effectiveness equivalent to existing PACS components.

Technological Characteristics

Software-based workstation running on standard PC hardware (Dual 400 MHz Pentium, 512 MB RAM). Connectivity via TCP/IP and GPIB. Supports DICOM 3.0, ACR NEMA 2.0, and proprietary formats. Image processing includes window/level, filtering, 3D/4D volume rendering (MIP, MinIP, surface rendering). AccuScore uses volumetric Agatston algorithm for calcium scoring. AccuScope provides virtual endoscopy with auto-flight path and collision detection. Software level of concern is Minor.

Indications for Use

Indicated for use as an image processing workstation software package for the viewing, manipulation, 3D/4D visualization, communication, and archiving of medical images (CT/MRI) by clinicians.

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

• AIDP (AccuImage Display Processor) (K961023)
• Imatron Ultra Access (K972903)
• InSight Diagnostic Imaging Workstation (K982535)
• Picker Voxel Q, Voyager (K962010)

Submission Summary (Full Text)

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## 510(k) Summary

K99824/

#### 1. Company Identification

AccuImage Diagnostics Corporation 400 Oyster Point Blvd. Suite 114 S. San Francisco, CA 94080 Toll Free: [phone]

#### 2. Official Correspondent

Gary J. Allsebrook Regulatory Affairs

#### 3. Date of Submission

June 25, 1999

#### 4. Device Name

| Classification Name: | Computed Imaging Device |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communications System<br>(PACS) |
| Proprietary Name: | AccuImage Diagnostics Corporation, AccuView<br>Diagnostic Imaging Software Package with<br>AccuScore, AccuAnalyze, AccuScope, AccuShade,<br>AccuVRT and AccuMIP Plug-ins |

### 5. Substantial Equivalence

AccuImage, AIDP (Acculmage Display Processor), K961023; AccuView, with AccuShade, AccuAnalyze, AccuVRT and AccuMIP

Imatron, Ultra Access, K972903; AccuScore.

InSight™, Diagnostic Imaging Workstation, K982535,and Picker, Voxel Q, Voyager, K962010; AccuScope.

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## 6. Device Description and Intended Use

The AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receive 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 communication, and them for ease of cost and maintenance. The use of Microsoft Windows 95/98/NT operating system makes the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins easy to use and capable of being integrated with other computer needs.

#### 7. Software

Acculmage Diagnostics Corporation certifies that the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins are 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".

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#### 9. Safety Concerns

The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.

#### 10. Substantial Equivalence

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

## AccuView (with AccuShade, AccuAnalyze, AccuVRT and AccuMIP Plugins

| Manufacturer | Acculmage | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name: | AccuView (with AccuShade, AccuAnalyze,<br>AccuVRT and AccuMIP Plugins) | AIDP (Predicate Device) |
| 510(k) Number: | | K961023 |
| Computer Platform: | Standard PC/Windows 95/98/NT, Dual 400 MHz<br>Pentium processor, 512 MByte RAM | Pentium/Windows 95, Single 300 MHz Pentium<br>processor, 256 MByte RAM |
| Communications | GPIB, TCP/IP | GPIB, TCP/IP |
| Image Format In: | Imatron Proprietary, ACR NEMA 2.0, DICOM<br>3.0 | Imatron Proprietary, ACR NEMA 2.0, DICOM<br>3.0 |
| Image Format Out: | BMP, TIFF, DICOM 3.0 | BMP |
| Image Archive: | SCSI 2-20Gbyte, CD-ROM | IDE Disk Drive, 1+Gbyte, CD-ROM |
| Image Display: | Color/Greyscale, CRT or Laptop LCD<br>Up to 1024x768, 8, 16 or 24 Bits | Color/Greyscale, CRT or Laptop LCD, Up to<br>512x512, 12 Bits |
| Image Processing: | Window Level, Pan, Zoom, Variable Smooth<br>Filter, Cine Display | Window Level, Pan, Zoom, Variable Smooth<br>Filter, Cine Display |
| Image Edit: | Manual segmentation by drawing a contour.<br>Segmentation by CT number threshold. | Manual segmentation by drawing a contour.<br>Segmentation by CT number threshold. |
| Volume Rendering: | Maximum, or Minimum Intensity Projection (MIP<br>MinIP) Radiographic Projection, Color<br>Rendering, Surface Rendering, Quick Volume<br>Rendering, Volume Rendering | Maximum, or Minimum Intensity Projection<br>(MIP MinIP) Radiographic Projection, Color<br>Rendering, Surface Rendering, Quick Volume<br>Rendering, Volume Rendering |

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# AccuScore Plugin

| | Acculmage<br>AccuScore | Imatron | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Acculmage<br>AccuScore | Ultra Access (Predicate Device feature) | |
| Name: | AccuScore | K972903 | |
| 510(K) Number | | | |
| Computer Platform: | Standard PC/Windows 95/98/NT, Dual 400 MHz Pentium processor, 512 MByte RAM | UNIX Operating System, Ultra SPARC Sun Workstation, 512 MByte RAM | |
| Image Format In: | Imatron Proprietary, ACR NEMA 2.0, DICOM 3.0 | Imatron Proprietary, ACR/NEMA 2.0, DICOM 3.0 | |
| Image Format Out: | BMP, TIFF, DICOM 3.0 | DICOM 3.0 | |
| Image Archive: | SCSI 2-20Gbyte, CD-ROM | SCSI 10 Gbyte | |
| Image Display: | Color/Greyscale, CRT or Laptop LCD<br>Up to 1024x768, 8, 16 or 24 Bits | Color/Greyscale, CRT 1680x1200, 24 Bits | |
| Image Processing: | Window Level, Pan, Zoom, Variable Smooth Filter, Cine Display, Slab views, Lesion editing | Window Level, Pan, Zoom, Variable Smooth Filter, Cine Display, Slab views, Examination of 3D volume for calcium | |
| Calcium Scoring: | 3D calcium score using volumetric Agatston algorithm, Equivalent calcium mass and volume determination, Manual identification of regions considered to be calcium | 3D calcium score using volumetric Agatston Algorithm, 2D traditional Agatston algorithm score, Equivalent calcium mass and volume computation, Automated heart surface finding, Automatic coronary artery identification, Semi-automated identification of regions that are considered calcium, User override of automatically identified regions | |
| Output Document: | Integrated report generation tool with user defined templates, Image annotation capacity | Integrated report generation tool with user defined templates | |
| Database management | Yes | Yes | |
| Manufacturer. | Acculmage | N.I.T. | Picker |
| Name: | AccuScope | Insight Diagnostic Imaging<br>Workstation (Predicate Device<br>Feature) | Voxel Q™, Voyager™<br>Package (Predicate Device<br>Feature) |
| 510(k) Number: | | K982535 | K962010 |
| Computer Platform: | Standard PC/Windows<br>95/98/NT, Dual 400 MHz<br>Pentium processor, 512<br>MByte RAM | Standard PC/Windows<br>95/98/NT, Dual 400 MHz<br>Pentium processor, 512 MByte<br>RAM | UNIX Operating System, SGI<br>Workstation, 256 MByte RAM,<br>Proprietary Array Processor |
| Image Format In: | Imatron Proprietary, ACR<br>NEMA 2.0, DICOM 3.0 | Imatron Proprietary, ACR<br>NEMA 2.0, DICOM 3.0 | Picker Proprietary, DICOM 3.0 |
| Image Format Out: | BMP, TIFF, DICOM 3.0 | DICOM 3.0 | Picker Proprietary, DICOM 3.0 |
| Image Archive: | SCSI 2-20Gbyte, CD-ROM | SCSI 2-20Gbyte, CD-ROM | SCSI 4 GByte, DAT(Digital<br>Archive Tape), MOD |
| Image Display: | Color/Greyscale, CRT or<br>Laptop LCD<br>Up to 1024x768, 8, 16 or 24<br>Bits | Color/Greyscale, CRT or<br>Laptop LCD<br>Up to 1024x768, 8, 16 or 24<br>Bits | Color/Greyscale, CRT<br>1680x1200, 24 Bits |
| Image Processing: | Window Level, Pan, Zoom,<br>Variable Smooth Filter, Cine<br>Display,<br>Axial/Coronal/Sagittal<br>inspection | Window Level, Pan, Zoom,<br>Variable Smooth Filter, Cine<br>Display, Axial/Coronal/Sagittal<br>inspection | Window Level, Pan, Zoom,<br>Variable Smooth Filter, Cine<br>Display, Axial/Coronal/Sagittal<br>inspection |
| Major Functionality: | Fly through anatomic cavities<br>and render the data on the<br>surface of the lumen | Fly through anatomic cavities<br>and render the data on the<br>surface of the lumen | Fly through anatomic cavities<br>and render the data on the<br>surface of the lumen as well as<br>the surrounding organs |
| Volume Rendering<br>of Flight Path | Yes | Yes, Real-time | Yes, via 4-D Angio™ Volume<br>Rendering |
| Surface Rendering<br>of Flight Path | No | Yes | Yes |
| Auto-Flight Path<br>Calculation | Yes | No | Yes |
| Auto Collision<br>Detect | Yes | No | Yes |
| User-directed flight<br>control | Yes | Yes | Yes |
| Adjustable Field-of-<br>View | Yes | No | No |
| Cine Display of<br>Flight-Path | Yes, AVI and MPEG format | Yes, AVI format | Yes, Proprietary format |

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## AccuScope Plugin .

:

:

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

SEP 2 3 1599

Acculmage Diagnostics Corporation C/O Mr. Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116

Dear Mr. Allsebrook:

Re:

K990241 AccuView Diagnostic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP Plug-Ins Dated: June 23, 1999 Received: June 28, 1999 Product Code: 90 LLZ Requiatory Class: II (two) 21 CFR 892.2050

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We have reviewed your Section 210(x) houldation of the indications for use stated in the enclosure) to legally delemined the device is substantialy equivalent for the manation to May 28, 1976, the enactnerity of the provisions of the marketed predicale devices matketed in merseas ified in accordance with the provisions of the provisions of the Medical Device Africanients, or to Gevices and have bother the devices, subject to the general controls, liceiner and Federal FOOD, Drug, and Cosmelle Not (not new ) f the Act include requirements for annual registration, listing of provisions of the Ac. The general Controls provisions of the Reviews in the more and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), in in a Cada of If your device is cassilled (see above) this can regulations affecting your device can be found in the Code of be subject to such authoriz. Existing major regalization defermination assumes ompliance with
Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalian Federal Regulations, Title 21, Factor equirements, as set forth in the Quality System Regulation (QS) for the Current Good Manufacturing Practice, and that, through periodic CS inspections, the Food and Medical Devices. General regulations For NY Life in and comply with the GMP regulation may result in the Edgest Orug Administration (rDA) will velly such associated in announcements concerning your device in the Federal registory action. In addition, FDA hilay publish furner announces on tot affect any obligation your
Register. Please note: this response to your premarket notification Se Register. Please noter this response to your promation in 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) in a classification for This relief will and anow you to begin marketing your as 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 from with from with ir you uestic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on
vitro diagnostic devices), please contact the Office of Co the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, the promotion and advanisms of the Misbranding by reference to premarket notification"(21 CFR 807.97). Other please note tre regulation entition, "Misblanding by roler the Division of Small Manufacturers general internation on your roop [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerety voy

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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## Page 1__of_1

510(k) Number (if known):

K990241

510(K) Number (II Kreath)
Device Name: Acculmage, AccuView Diagnostic Imaging Workstation
Device Name: Acculmage, AccuView Diagnostic Imaging Workstation

Indications For Use:

Indications For Ose.

The product is an image processing workstation software package designed to run The product is an image processing workstation software package compressions
on standard PC hardware is all "off-the-shel" stad ard copiled by and l he product is an may be purchased in all "oft-the-shell" standard opplied by
on standard PC hardware. The hardware is all "oft-the shops" (for the more of may in the main on standad i C marthased independently by the end user of of of of of of of of of of of of of of of of of of of of of of one from
Acculmage. The Acculinage, Acculview components and may be of the software receives integorial real time viewing,
Acculmage. The Acculimat CT or MR and perform real time Accumings: " The Market Such as CT or MRI and penom 1981 - 1988
medical scanning devices, such as CT or MRI and pensunication, and archiving.
Image manipulation, 3D and 4D vi

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> | OR | Over-the-Counter Use |
|----------------------|---------------|----|----------------------|
| (Per 21 CFR 901.109) | | | |

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K990241 |
|---------------|---------|
|---------------|---------|