The RATTAN IMACS™ system is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Device Description

RATTAN IMACS™ system is a software picture archiving and communications system that provides users with capabilities relating to the capture, acceptance, transfer, display, storage, and digital processing of medical images. RATTAN IMACS™ system includes features to access and manage medical imaging studies from a film digitizer (FD), cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.

The device is designed to be deployed over conventional networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images.

AI/ML Overview

The provided text is a 510(k) Summary and related correspondence for the RATTAN IMACS™ system. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets said criteria, as would typically be found in a performance study report or clinical validation.

The RATTAN IMACS™ system is described as a Picture Archiving Communications System (PACS) designed for the capture, acceptance, transfer, display, storage, and digital processing of medical images. Its clearance is based on its functional similarity to a previously cleared predicate device (MAROSIS PACS, K012844).

Therefore, I cannot fulfill the request to provide acceptance criteria and a study design based on the input document. The document confirms that:

The device is a software-only PACS, which means it primarily handles images and data, rather than generating new medical images or directly interacting with patients.
Its regulatory pathway is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves comparing technological characteristics, indications for use, and safety/effectiveness profiles, rather than conducting new performance studies against specific acceptance criteria for algorithm performance.
The document states that the "Level of Concern for potential hazards have been classified as 'minor'" and that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." These statements highlight that the device is intended to be used by trained professionals, and human interpretation is a critical part of the clinical workflow, implying that its standalone algorithmic performance (if any advanced image processing is involved) is not the sole determinant of safety and effectiveness.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) pathway for this type of device typically relies on demonstrating equivalence through documentation of functionalities and adherence to standards, rather than new, quantitative performance studies against specific clinical endpoints or reader performance.

Summary

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SEP 2 5 2003

K032176
Page 1 of 2

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: June 15, 2003

Submitter's Information: 21 CFR 807.92(a)(1) Rattan Information Corporation 6FI .- 3, No. 103, Sec. 4, NanJing E. Rd. SungSang District 105 Taipei, Taiwan, R.O.C.

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name: RATTAN IMACS™ by Rattan Information Corporation Common Name: Picture Archiving Communications System Device Classification: 892.2050 Classification Name: System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Requlation Number 892.2050 510(k) Number K012844 Device Name MAROSIS PACS Applicant MAROTECH, INC Product Code LLZ Decision Date 11/08/2001 Decision SUBSTANTIALLY EQUIVALENT (SE)

Device Description: 21 CFR 807 92(a)(4)

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Image /page/1/Picture/0 description: The image shows the logo for Rattan Information Corp. The logo consists of the letter R on the left, followed by the company name in both Chinese and English. The Chinese characters are above the English text, which reads "Rattan Information Corp."

K032176
Page 2 of 2

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for RATTAN IMACS™ system contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

RATTAN IMACS™ system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards have been classified as "minor".

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Rattan Information Corporation % Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

Re: K032176

Trade/Device Name: RATTAN IMACSTM System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II

Product Code: 90 LLZ Dated: June 15, 2003 Received: July 16, 2003

Dear Ms. Chen:

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 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 yours,

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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RATTAN INFORMATION CORPORATION

Page 1 of -1

(Indications for Use Form)

510(k) Number: K032176

Device Name: RATTAN IMACS™ system by Rattan Information Corporation

Indications for Use:

Typical users of this system are trained professionals, nurses, and technicians.

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

David R. Lyon

(Divis Division of Reproductive. Abdominal and Radiological Devices 510(k) Number

(Optional Format 1-2-96)

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).