PACS PLUS 5TH EDITION

K083658 · Medical Standard Co., Ltd. · LLZ · Jul 7, 2009 · Radiology

Device Facts

• Record ID: K083658
• Device Name: PACS PLUS 5TH EDITION
• Applicant: Medical Standard Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

PACS PLUS 5" EDITION is software that receives digital images and data from various sources (e.g. 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. Options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Device Story

PACS PLUS 5th EDITION is a software-based Picture Archiving and Communication System (PACS). It ingests digital medical images and data from diverse sources, including CT, MR, ultrasound, R/F units, and radiographic devices. For non-DICOM sources, it utilizes a DICOM gateway or film digitizers to convert inputs into DICOM-compliant files. The system enables storage, network distribution, and display of images at distributed clinical locations. It supports features such as telecommunications, teleconferencing, and image reading/manipulation. Operated by trained professionals, physicians, nurses, and technicians, the system provides tools for clinical review. It does not contact patients or control life-sustaining equipment; clinical decisions remain the responsibility of the healthcare provider, who interprets the displayed images. The system facilitates efficient access to medical imaging, supporting diagnostic workflows.

Clinical Evidence

No clinical data. Bench testing only. The device is a software-based image processing system that does not contact patients or control life-sustaining equipment. Performance is supported by hazard analysis and adherence to established standards (DICOM, JPEG, SMPTE).

Technological Characteristics

Software-based PACS for digital medical image management. Supports DICOM standard, JPEG compression, and SMPTE test patterns. Connectivity via network for distributed image access. Operates on standard imaging workstations. Hazard analysis classified as 'Minor' level of concern.

Indications for Use

Indicated for trained professionals, physicians, nurses, and technicians to receive, store, communicate, process, and display digital medical images from various imaging sources for diagnostic review, including mammography. Lossy compressed mammographic images are contraindicated for diagnostic review.

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

• PACS Partner (K042311)

Submission Summary (Full Text)

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## 510(K) SUMMARY

[as required by 807.92(c)]

JUL - 7 2009

# A. 510k Number: Ko83658

B. Applicant:

Company name: Medical Standard Co.,Ltd Address: Hanyang Institute of Technology 17, Haengdang-dong Sungdong-ku Seoul, Korea, 133-791

Tel .: [phone] (ext: 303)

Dir: [phone]

+82.2.2282.6690 Fax:

Email: [e-mail]

C. Proprietary and Established Names: Medical Standard Inc.

#### D. Regulatory Information

Product Code

Device Classification Name Regulation Number Device Name Applicant

System, Image Processing, Radiological 892.2050 PACS Plus 5th edition Medical Standard Co. Ltd. LLZ

#### E. Intended use

PACS PLUS 5" EDITION is software that receives digital images and data from various sources (e.g. 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.

Options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

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#### F. Device Description

PACSPLUS 5TH Edition™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to PACSPLUS 517 Edition ™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.

G. Substantial Equivalence Information

1. Predicate Device - K042311

Device Classification Name Regulation Number Device Name Applicant

Product Code

System, Image Processing, Radiological 892-2050 PACS Partner Medical Standard Co. Ltd. LLZ

2. The 510(k) Pre-Market Notification for PACS Plus 5th edition contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

PACS Plus 5th edition 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 has been classified as "Minor".

- H. Standard / Guidance Document Referenced (if applicable)
Digital Imaging and Communications in Medicine (DICOM) Standard;

Joint Photographic Experts Group (JPEG) Standard,

Society of Motion Picture and Television Engineers (SMPTE) Test Pattern

- I. Performance Characteristics (If/when applicable)
PACS Plus 5th edition is a software product that handles digital medical images. 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.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL - 7 2009

Medical Standard Co., Ltd. % Mr. Brandon Choi Official Correspondent PATS Corporation 49 Candlewood Way BUENA PARK CA 90621

Re: K083658

Trade/Device Name: PACS PLUS 5th EDITION Software Regulation Number: 21 CFR 892.2050 . . . . Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 6, 2009 Received: May 22, 2009

#### Dear Mr. Choi:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K 0 83658

Device Name: PACS PLUS 5th EDITION software by Medical Standard Co. Ltd

Indications For Use: .

PACS PLUS 5th EDITION is software that receives digital images and data from various sources (e.g. 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.

Options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over - The - Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Walter Hemm

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083658