PACS Software Solution 2003 is intended to be used by radiologists and other medical professionals for purposes of diagnosis, or for clinical review, by viewing medical images on digital display devices or hard copy printouts. PSS03 provides an efficient interface to medical images and manages the archiving of medical images for short and long term storage. PSS03 is intended to be used with imaging equipment (e.g., Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Digital Radiography (DR), Ultrasound (US), etc.) and patient information systems (e.g., Hospital Information Systems (HIS), Radiology Information Systems (RIS)) approved for medical use.

PACS Software Solution 2003 is used to acquire, process, display, evaluate, archive, print and distribute DICOM compliant images for clinical purposes. Images may be acquired from imaging modalities such as CR, CT, MR, X-Ray, and other devices.

Device Description

PACS Software Solution 2003 (PSS03)' is proprietary software used in conjunction with computer hardware to provide a Picture Archiving and Communication System. PSS03 has been designed to manage medical imaging data from various imaging devices (e.g. Magnetic Resonance Imaging, Computerized Tomography, Digital Radiography, Ultrasound, etc.). Management of medical imaging data from these devices, enabled by PSS03, includes display tools, the support of industry standard communication protocols (e.g. Transfer Control Protocol/Internet Protocol, Digital Communication in Medicine, Ethernet, etc.) and archiving of data using hierarchical protocols. The system provides redundant storage of the exam data.

PSS03 accommodates individual user preferences by automatically displaying medical images in a presentation format unique to the user and to the type of exam selected.

PSS03 is highly scalable, providing a small facility or a large enterprise of facilities the same functionality.

AI/ML Overview

This 510(k) submission for "PACS Software Solution 2003" is a traditional clearance based on substantial equivalence to a predicate device, "Paper Film - PACS". As such, it does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment that would be present in a submission for a novel AI/ML medical device.

Therefore, many of the requested categories of information cannot be provided from this document. The device in question is a Picture Archiving and Communication System (PACS) software, which is infrastructure for managing medical images, not a diagnostic algorithm itself.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission for a PACS software, not a diagnostic algorithm. Performance is assessed against the predicate device's capabilities.
Reported Device Performance: The document states that the new system has "equivalent design features, methods of use, and equivalent functional characteristics as the predicate device" and "raises no new safety or effectiveness issues." It highlights improvements like "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also mentions "smooth" and "sharp" filtering of images using a low-pass blurring kernel, and 8-bit and 12-bit JPEG compression, similar to the predicate.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. This is a PACS software, not a device that runs diagnostic algorithms on a test set of medical images in the way an AI/ML device would. The evaluation is functional and comparative to a predicate PACS.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No "ground truth" in the diagnostic sense is established for this PACS software.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a PACS software, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a PACS software. Its function is to facilitate human review and management of images, not to perform standalone diagnostic tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is PACS software, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary based on provided text:

This 510(k) submission for "PACS Software Solution 2003" asserts substantial equivalence to a previously cleared PACS known as "Paper Film - PACS" (K940664). The primary argument for equivalence is based on:

Same Indications for Use: Both systems are intended for radiologists and other medical professionals to view medical images, for diagnosis or clinical review, and manage the archiving of medical images.
Equivalent Design Features: Both operate under Open Windows on a Unix-based operating system and consist of image servers, database servers, and workstations for image acquisition, processing, rendering, archiving, printing, and distribution.
Technological Characteristics: Both provide "smooth" and "sharp" filtering, and utilize 8-bit and 12-bit JPEG compression.
Improvements: The new system takes advantage of "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also enhances patient integrity by assigning a Radiology Information System key in addition to the Medical Record Number and patient's name.
Calibration: Display devices for both are calibrated using standard SMPTE patterns and/or graphics card software.

The submission confirms that the device "raises no new safety or effectiveness issues" compared to its predicate. The evaluation focuses on functional equivalence and updated technological capabilities of the PACS system rather than diagnostic performance metrics or clinical study outcomes typical for AI/ML diagnostic tools.

Summary

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1633624

Image /page/0/Picture/1 description: The image shows the word "Canon" in a bold, stylized font. The letters are thick and have a slightly rounded appearance. The word is in black and the background is white.

CANON U.S.A., INC. 15955 Alton Parkway Irvine, CA 92618-3731 Tel.: (949) 753-4000

www.usa.canon.com

DEC 1 5 2003

510(k) Summary

Submitter:	Canon U.S.A., Inc.Canon Medical Systems Division15955 Alton ParkwayIrvine, CA 92618
Contact person:	Sean M. Curry16787 Bernardo Center Drive, Suite A1San Diego, CA 92128
Phone:	(858) 675-8200
FAX:	(858) 675-8201
Proprietary name:	PACS Software Solution 2003
Common name:	Picture Archiving and Communication System (PACS)
Classification:	892.2050
Product Code:	LLZ
Classification name:	System, Imaging Processing, Radiological
Substantial equivalence claimed to:

Substantial equivalence claimed to: K940664: Paper Film - PACS

Description:

PSS03 accommodates individual user preferences by automatically displaying medical images in a presentation format unique to the user and to the type of exam selected.

All referenced product names mentioned throughout this document, and other marks, are or may be trademarks of their respective owners.

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PSS03 is highly scalable, providing a small facility or a large enterprise of facilities the same functionality.

Intended use:

PACS Software Solution 2003 (PSS03) is intended to be used by radiologists and other I ACD Bottware Dolunion 2008 y medical images on digital display devices or hard copy motived professionals of diagnosis, or for clinical review, PSS03 provides an efficient princis. For parposes or clag.com, nanages the archiving of medical images for short used linerface. Additionally, I BO% interf. PSS03 in intended to be used with imaging equipment (e.g., Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Digital Radiography (DR), Ultrasound (US), etc.) and patient information systems (e.g., Hospital Information Systems (HIS), Radiology Information Systems (RIS)) approved for medical use.

Summary of technological characteristics in comparison to predicate device:

The PACS Software Solution 2003 and the Paper Film - PACS, are Picture Archiving and Communication Systems (PACS) that operate under Open Windows on a Unix based operating system. They both consist of one or more of the following: image server, database server, and workstations for acquiring, processing, rendering, archiving, printing and distributing images. PACS Software Solution 2003 has been updated to take advantage of newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices.

The viewing applications in both systems provide "smooth" and "sharp" filtering of images. A low-pass blurring kernel is used for smoothing. Both systems also utilize 8 bit and 12 bit compression using JPEG format.

The new system ensures patient integrity by assigning a Radiology Information System key to cach exam, in addition to the Medical Record Number and the patient's name (which was used with the predicate device).

As with the predecessor, the PACS Software Solution 2003 display devices are calibrated using a standard SMPTE pattern and/or calibration software provided by the graphics card supplier.

The PACS Software Solution 2003 system has the same Indications for Use, equivalent design features, methods of use, and equivalent functional characteristics as the predicate device and therefore raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2003

Canon U.S.A., Inc. % Mr. Sean Curry Chief Operating Officer Certified Software Solutions, Inc. 16787 Bernardo Center Drive, Suite A1 SAN DIEGO CA 92128

Re: K033624 Trade/Device Name: PACS Software Solution 2003 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 11, 2003 Received: November 18, 2003

Dear Mr. Curry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA), 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko3 362 4

Device Name: PACS Software Solution 2003

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Daniel A. Szyrmer

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .

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).