UNIWEB, VERSION 5.0

K071166 · Electronic Business Machine Co., Ltd. (Ebm) · LLZ · Jul 23, 2007 · Radiology

Device Facts

• Record ID: K071166
• Device Name: UNIWEB, VERSION 5.0
• Applicant: Electronic Business Machine Co., Ltd. (Ebm)
• Product Code: LLZ · Radiology
• Decision Date: Jul 23, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, 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 a computer network at distributed locations. UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats. UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities. UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting. UniWeb™ will be utilized only on FDA approved monitors used for mammography. Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians. This product will only use lossless compression or no compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals.

Device Story

UniWeb v5.0 is a Picture Archiving and Communication System (PACS) designed for clinical environments. It receives digital images and data from various modalities (e.g., FFDM, MR, CT, ultrasound, CR/DR). The system stores, communicates, processes, and displays these images across computer networks. For mammography, it displays post-processed FFDM images in DICOM format using only lossless or no compression. It is intended for primary diagnostic interpretation by trained professionals (physicians, nurses, technicians) using FDA-approved mammography monitors. The device facilitates clinical decision-making by providing a centralized platform for viewing and interpreting diagnostic images.

Clinical Evidence

No clinical data provided. The device relies on its function as a standard PACS for image display and communication.

Technological Characteristics

PACS software for digital image management. Supports DICOM standard. Operates on networked computer systems. Requires use of FDA-approved monitors for mammography interpretation. Implements lossless or no-compression protocols for mammography images.

Indications for Use

Indicated for use by trained professionals (physicians, nurses, technicians) for the storage, communication, processing, and display of digital medical images, specifically including FFDM post-processed images for primary diagnostic interpretation in mammography settings.

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).

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Electronic Business Machine Co., Ltd. c/o Mr. Andy Yew Engineer North America EBM Technologies, Inc. 1600 Kapiolani Blvd., Suite 1300 HONOLULU HI 96814

Re: K071166

Trade/Device Name: UniWeb", version 5.0 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2007 Received: June 29, 2007

Dear Mr. Yew:

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.

JUL 2 3 2007

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/0/Picture/9 description: The image shows a circular seal with the text "FDA Certified" and the years "1906-2016". The seal has a star design around the perimeter. The letters "FDA" are prominently displayed in the center of the seal. There are three stars at the bottom of the seal.

Protecting and Promoting Public Health

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

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.

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 this letter:

> 21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 240-276-0120 (Radiology) 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

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

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

## JUL 23 2007

## INDICATIONS FOR USE STATEMENT

510(K) Number: UniWeb™ Device Name:

UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, 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 a computer network at distributed locations.

UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats.

UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities.

UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting.

UniWeb™ will be utilized only on FDA approved monitors used for mammography.

Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians.

This product will only use lossless compression or no compression when displaying mammography images.

For image diagnosis, this device can only be used by trained professionals.

Prescription Use x

line)

AND/OR Over-the-Counter Use:

(Please do not write below this

(Concurrence of CDRH, Office of Device Evaluation)

Villas Reever

(Division Sign-Uff) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number