(241 days)
Not Found
No
The summary describes standard image processing and visualization techniques common in medical imaging workstations, with no mention of AI, ML, or related concepts.
No.
The device is described as an image processing workstation software package that receives image files from medical scanning devices for viewing, manipulation, and visualization. It does not perform any direct therapeutic action or deliver treatment.
Yes
The 'Intended Use / Indications for Use' directly states "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." The core function of processing and displaying medical images for review by professionals indicates it's used in the diagnostic process. Furthermore, the 'Device Description' refers to it as the "AccuView Diagnostic Imaging Workstation Software Package," implying its diagnostic purpose.
Yes
The device is described as a "software package" designed to run on "standard PC hardware" which is "off-the-shelf". The description focuses solely on the software's functions (image processing, viewing, communication, archiving) and explicitly states the hardware is separate and can be purchased independently. This indicates the submission is for the software component only.
Based on the provided text, 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 description clearly states that the device receives image files from medical scanning devices like CT and MRI. It performs image processing, viewing, manipulation, and archiving.
- Lack of biological sample analysis: There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis. Its function is solely focused on processing and presenting medical images.
The device is a medical image processing workstation, which falls under a different category of medical devices than IVDs.
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 supplied by AccuImage or may be purchased independently by the end user. The AccuImage, AccuView components of the software receives image files from medical scanning devices, such as CT or MRI and perform real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanning devices, such as 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K961023, K972903, K982535, K962010
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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, AccuView |
| Diagnostic Imaging Software Package with | |
| AccuScore, 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
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".
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 MHz | |
| Pentium processor, 512 MByte RAM | Pentium/Windows 95, Single 300 MHz Pentium | |
| processor, 256 MByte RAM | ||
| Communications | GPIB, TCP/IP | GPIB, TCP/IP |
| 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 | BMP |
| Image Archive: | SCSI 2-20Gbyte, CD-ROM | IDE Disk Drive, 1+Gbyte, CD-ROM |
| Image Display: | Color/Greyscale, CRT or Laptop LCD | |
| Up to 1024x768, 8, 16 or 24 Bits | Color/Greyscale, CRT or Laptop LCD, Up to | |
| 512x512, 12 Bits | ||
| Image Processing: | Window Level, Pan, Zoom, Variable Smooth | |
| Filter, Cine Display | Window Level, Pan, Zoom, Variable Smooth | |
| Filter, 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 (MIP | |
| MinIP) Radiographic Projection, Color | ||
| Rendering, Surface Rendering, Quick Volume | ||
| Rendering, Volume Rendering | Maximum, or Minimum Intensity Projection | |
| (MIP MinIP) Radiographic Projection, Color | ||
| Rendering, Surface Rendering, Quick Volume | ||
| Rendering, Volume Rendering |
3
AccuScore Plugin
| | Acculmage
AccuScore | Imatron | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Acculmage
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
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
Workstation (Predicate Device
Feature) | Voxel Q™, Voyager™
Package (Predicate Device
Feature) |
| 510(k) Number: | | K982535 | K962010 |
| Computer Platform: | Standard PC/Windows
95/98/NT, Dual 400 MHz
Pentium processor, 512
MByte RAM | Standard PC/Windows
95/98/NT, Dual 400 MHz
Pentium processor, 512 MByte
RAM | UNIX Operating System, SGI
Workstation, 256 MByte RAM,
Proprietary Array Processor |
| Image Format In: | Imatron Proprietary, ACR
NEMA 2.0, DICOM 3.0 | Imatron Proprietary, ACR
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
Archive Tape), MOD |
| Image Display: | Color/Greyscale, CRT or
Laptop LCD
Up to 1024x768, 8, 16 or 24
Bits | Color/Greyscale, CRT or
Laptop LCD
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,
Axial/Coronal/Sagittal
inspection | Window Level, Pan, Zoom,
Variable Smooth Filter, Cine
Display, Axial/Coronal/Sagittal
inspection | Window Level, Pan, Zoom,
Variable Smooth Filter, Cine
Display, Axial/Coronal/Sagittal
inspection |
| Major Functionality: | Fly through anatomic cavities
and render the data on the
surface of the lumen | Fly through anatomic cavities
and render the data on the
surface of the lumen | Fly through anatomic cavities
and render the data on the
surface of the lumen as well as
the surrounding organs |
| Volume Rendering
of Flight Path | Yes | Yes, Real-time | Yes, via 4-D Angio™ Volume
Rendering |
| Surface Rendering
of Flight Path | No | Yes | Yes |
| Auto-Flight Path
Calculation | Yes | No | Yes |
| Auto Collision
Detect | Yes | No | Yes |
| User-directed flight
control | Yes | Yes | Yes |
| Adjustable Field-of-
View | Yes | No | No |
| Cine Display of
Flight-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):
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 |
|---|---|
| --------------- | --------- |