The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard supplied by and may be purchased independently by the end user or from AccuImage. The AccuImage, AccuView Diagnostic Imaging Workstation Software Package with Plug-ins 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 Description

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.

AI/ML Overview

This document is a 510(k) Summary for the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins. It is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed devices. As such, it describes the device and its intended use but does not include detailed acceptance criteria or a study proving the device meets those criteria in the way a performance study report would.

Here's an analysis based on the provided text, highlighting what is included and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on functional comparisons and technical specifications rather than quantitative performance metrics against predefined acceptance criteria. The tables provided compare the features and technical specifications of the AccuView components with their respective predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As this is a 510(k) submission for a diagnostic imaging workstation software package, the focus is on functional equivalence and safety, not on a clinical performance study with a test set of patient cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. No clinical performance study is described that would involve expert review and ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set or clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided. The device is an imaging workstation and software package, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or aiding human readers in a way that would be assessed by an MRMC study measuring reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided. The device is a workstation for human interpretation and manipulation of medical images; it's not a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used

This information is not provided as no clinical performance study requiring ground truth is described.

8. The Sample Size for the Training Set

This information is not provided. The document describes software development and testing procedures but not the training of a machine learning model, which would involve a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as no training set for a machine learning model is mentioned.

Summary of what is present in the document relevant to device description and regulatory process (but not detailed performance outcomes):

The document outlines:

Device Name: AccuImage Diagnostics Corporation, AccuView Diagnostic Imaging Software Package with AccuScore, AccuAnalyze, AccuScope, AccuShade, AccuVRT and AccuMIP Plug-ins.
Intended Use: Receives image files from medical scanning devices (CT or MRI) and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving.
Software Development and Testing: "AccuImage 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 cover product specifications, coding, testing, validation testing, and field maintenance.
Hazard Analysis: Performed throughout the definition, design, coding, and testing phases. Concluded that the "Level of Concern" is "Minor," as failures are primarily related to computer system components and "None of these failures are expected to materially contribute to patient death or injury."
Substantial Equivalence: Demonstrated by comparing the device's characteristics and functions (e.g., computer platform, communication, image format, display, processing, specific plug-in functionalities like calcium scoring, and virtual endoscopy) against predicate devices (AIDP, Imatron Ultra Access, InSight Diagnostic Imaging Workstation, and Picker Voxel Q/Voyager) via detailed tables. This comparison forms the basis of the FDA's clearance, indicating that the new device is as safe and effective as existing legally marketed devices.

Summary

{0}------------------------------------------------

510(k) Summary

K99824/

1. Company Identification

AccuImage Diagnostics Corporation 400 Oyster Point Blvd. Suite 114 S. San Francisco, CA 94080 Toll Free: (877) 875-0192

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(PACS)
Proprietary Name:	AccuImage Diagnostics Corporation, AccuViewDiagnostic Imaging Software Package withAccuScore, AccuAnalyze, AccuScope, AccuShade,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.

{1}------------------------------------------------

6. Device Description and Intended Use

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".

{2}------------------------------------------------

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,AccuVRT and AccuMIP Plugins)	AIDP (Predicate Device)
510(k) Number:		K961023
Computer Platform:	Standard PC/Windows 95/98/NT, Dual 400 MHzPentium processor, 512 MByte RAM	Pentium/Windows 95, Single 300 MHz Pentiumprocessor, 256 MByte RAM
Communications	GPIB, TCP/IP	GPIB, TCP/IP
Image Format In:	Imatron Proprietary, ACR NEMA 2.0, DICOM3.0	Imatron Proprietary, ACR NEMA 2.0, DICOM3.0
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 LCDUp to 1024x768, 8, 16 or 24 Bits	Color/Greyscale, CRT or Laptop LCD, Up to512x512, 12 Bits
Image Processing:	Window Level, Pan, Zoom, Variable SmoothFilter, Cine Display	Window Level, Pan, Zoom, Variable SmoothFilter, Cine Display
Image Edit:	Manual segmentation by drawing a contour.Segmentation by CT number threshold.	Manual segmentation by drawing a contour.Segmentation by CT number threshold.
Volume Rendering:	Maximum, or Minimum Intensity Projection (MIPMinIP) Radiographic Projection, ColorRendering, Surface Rendering, Quick VolumeRendering, Volume Rendering	Maximum, or Minimum Intensity Projection(MIP MinIP) Radiographic Projection, ColorRendering, Surface Rendering, Quick VolumeRendering, Volume Rendering

{3}------------------------------------------------

AccuScore Plugin

	AcculmageAccuScore	Imatron
Manufacturer:	AcculmageAccuScore	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 LCDUp 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 ImagingWorkstation (Predicate DeviceFeature)	Voxel Q™, Voyager™Package (Predicate DeviceFeature)
510(k) Number:		K982535	K962010
Computer Platform:	Standard PC/Windows95/98/NT, Dual 400 MHzPentium processor, 512MByte RAM	Standard PC/Windows95/98/NT, Dual 400 MHzPentium processor, 512 MByteRAM	UNIX Operating System, SGIWorkstation, 256 MByte RAM,Proprietary Array Processor
Image Format In:	Imatron Proprietary, ACRNEMA 2.0, DICOM 3.0	Imatron Proprietary, ACRNEMA 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(DigitalArchive Tape), MOD
Image Display:	Color/Greyscale, CRT orLaptop LCDUp to 1024x768, 8, 16 or 24Bits	Color/Greyscale, CRT orLaptop LCDUp to 1024x768, 8, 16 or 24Bits	Color/Greyscale, CRT1680x1200, 24 Bits
Image Processing:	Window Level, Pan, Zoom,Variable Smooth Filter, CineDisplay,Axial/Coronal/Sagittalinspection	Window Level, Pan, Zoom,Variable Smooth Filter, CineDisplay, Axial/Coronal/Sagittalinspection	Window Level, Pan, Zoom,Variable Smooth Filter, CineDisplay, Axial/Coronal/Sagittalinspection
Major Functionality:	Fly through anatomic cavitiesand render the data on thesurface of the lumen	Fly through anatomic cavitiesand render the data on thesurface of the lumen	Fly through anatomic cavitiesand render the data on thesurface of the lumen as well asthe surrounding organs
Volume Renderingof Flight Path	Yes	Yes, Real-time	Yes, via 4-D Angio™ VolumeRendering
Surface Renderingof Flight Path	No	Yes	Yes
Auto-Flight PathCalculation	Yes	No	Yes
Auto CollisionDetect	Yes	No	Yes
User-directed flightcontrol	Yes	Yes	Yes
Adjustable Field-of-View	Yes	No	No
Cine Display ofFlight-Path	Yes, AVI and MPEG format	Yes, AVI format	Yes, Proprietary format

{4}------------------------------------------------

AccuScope Plugin .

{5}------------------------------------------------

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 (301) 594-4613. 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

{6}------------------------------------------------

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		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
---------------	---------

Regulation Number and Section

§ 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).