SAMSUNG RAYPAX DISPLAY WORKSTATION

K992306 · Samsung Sds Co., Ltd. · LLZ · Sep 22, 1999 · Radiology

Device Facts

• Record ID: K992306
• Device Name: SAMSUNG RAYPAX DISPLAY WORKSTATION
• Applicant: Samsung Sds Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations. The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

Device Story

RAYPAX Display Workstation receives digital medical images/data from various imaging sources (CT, MR, Ultrasound, etc.) via DICOM 3.0; stores, processes, and displays images for clinical review. Used in radiology departments by physicians, nurses, and technicians. Enables image transfer to other PACS via DICOM network and export to bitmap format. Provides workflow management for radiology. Supports clinical decision-making by allowing trained professionals to interpret images; no patient contact; no life-sustaining function.

Clinical Evidence

No clinical data. Bench testing only; hazard analysis performed with all hazards classified as Minor.

Technological Characteristics

Digital imaging workstation; DICOM 3.0 compatible; networked; software-based image processing and display; no patient-contacting materials; non-life-sustaining.

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to receive, store, communicate, process, and display digital medical images from various sources (CT, MR, Ultrasound, R/F, CR/DR, etc.) across 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).

Predicate Devices

• 02-Workstation & PACS View Software (K973959)

Submission Summary (Full Text)

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K99 2306

# SEP 22 1999

## 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 30, 1999

#### Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNG SDS CO., LTD 707-19, Yoksam-Dong, Kangnam-Gu, Seoul, South Korea, 135-080

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

| Trade Name: | Samsung RAYPAX™ Display Workstation System |
|------------------------|-----------------------------------------------|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication accessory |
| Device Classification: | 21 CFR 892.2020 |

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

| Manufacturer: | Olicon Imaging Systems, Inc |
|----------------------------------|-------------------------------------|
| Device: | 02-Workstation & PACS View Software |
| 510(k) Number: | K973959 |
| Date Received: | 10/16/97 |
| Decision Date: | 12/22/97 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: | Radiology |
| Panel Code device classified by: | Radiology |
| Product Code: | 90 LMD |
| Classification: | Class II |

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

The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.

Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.

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

The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

#### 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 printed.

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

The 510(k) Pre-Market Notification for the Samsung Display Workstation contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

- The RAYPAX™ Display Workstation system has been and will be manufactured in 1. accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- The submission contains the results of a hazard analysis and all potential hazards 2. have been classified as Minor.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

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SEP 2 2 1999

Samsung SDS Co., LTD. C/O Mr. Carl Aletto OTECH. Inc. 2001 East Oakshores Drive Aubrey, TX 76227

Re:

K992306 Samsung RAYPAX™ Display Workstation Dated: June 30, 1999 Received: July 9, 1999 Regulatory Class: II (TWO) Product Code: 90 LLZ 21 CFR 892.2050

Dear Mr. Aletto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# (Indications for Use Form)

510(k) Number:

## Device Name:

Samsung SDS Co. Ltd. RAYPAX™ Display Workstation System

## Indications for Use:

The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| ministen Circ<br>Official | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Annual design of the consideration<br><br>------- |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devig

510(k) Number K992346

OR

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)