UNISIGHT SYSTEM WITH UNIGATE

K023394 · Electronic Business Machine Co., Ltd. (Ebm) · LLZ · Jan 7, 2003 · Radiology

Device Facts

• Record ID: K023394
• Device Name: UNISIGHT SYSTEM WITH UNIGATE
• Applicant: Electronic Business Machine Co., Ltd. (Ebm)
• Product Code: LLZ · Radiology
• Decision Date: Jan 7, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

UniSight™ system with UniGate™ is a device that receives digital images and data from various sources (including but not limited to 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 network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

Device Story

EBM UniSight™ System with UniGate™ functions as a Picture Archiving and Communication System (PACS). It receives digital images and data from diverse imaging modalities (CT, MR, ultrasound, R/F, CR/DR, secondary capture devices). The system stores, communicates, processes, and displays these images across distributed computer networks. Operated by trained healthcare professionals (physicians, nurses, technicians) in clinical environments, the device facilitates the management and viewing of diagnostic imaging data. By enabling centralized or distributed access to patient images, it supports clinical workflow, diagnostic review, and decision-making by healthcare providers.

Clinical Evidence

No clinical data provided; device is a PACS system subject to standard regulatory review for imaging software.

Technological Characteristics

PACS software system; operates on computer networks; receives digital inputs from various imaging modalities (CT, MR, US, R/F, CR/DR); supports storage, communication, processing, and display of medical images. Connectivity via standard computer network infrastructure.

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to store, communicate, process, and display digital medical images and data received from various imaging sources (CT, MR, ultrasound, R/F, CR/DR) across distributed computer networks.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 7 2003

Electronic Business Machine Co., Ltd. % Mr. David Lin North America EBM Technologies, Inc. 1600 Kapiolani Boulevard, Suite 1224 HONOLULU HI 96814

Re: K023394

Trade/Device Name: EBM UniSight™ System with UniGate™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 2, 2002 Received: October 9, 2002

Dear Mr. Lin:

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 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] 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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## Indications for Use Statement

| 510(k) Number<br>(if known) | K023394 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EBM UniSight™ System with UniGate™ |
| Indications for Use | UniSight™ system with UniGate™ is a device that receives<br>digital images and data from various sources (including but not<br>limited to CT scanners, MR scanners, ultrasound systems, R/F<br>Units, computed & direct radiographic devices, secondary capture<br>devices, scanners, imaging gateways or other imaging sources).<br>Images and data can be stored, communicated, processed and<br>displayed within the system and or across computer network at<br>distributed locations. Typical users of this system are trained<br>professionals, including but not limited to physicians, nurses and<br>technicians. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *_*_

OR

(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023394

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