(79 days)
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.
This document is a 510(k) summary for the Samsung RAYPAX™ Film Digitizer System. It describes the device's purpose, comparison to a predicate device, and confirms substantial equivalence to legally marketed devices. However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on regulatory compliance and the device's technical characteristics and indications for use, not on a detailed analysis of its performance or the studies conducted to prove its efficacy against specific acceptance criteria.
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SEP d lagg
Image /page/0/Picture/1 description: The image shows the word "RAYPAX" in a stylized font. The "R" is large and bold, while the rest of the letters are smaller and have a textured appearance. The overall impression is of a logo or brand name.
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, 1999
Submitter's Information: 21 CFR 807.92(a)(1)
SAMSUNG SDS CO., LTD
707-19, Yoksam-Dong, Kangnam-Gu, Seoul, Korea, 135-080
Seoul, Korea, 135-000
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
Samsung RAYPAX™ Film Digitizer System Trade Name: Laser Film Digitizer Common Name: Device Classification: 21 CFR 892.2040
Predicate Device: 21 CFR 807. 92(a)(3)
Manufacturer: VIDAR SYSTEMS CORPORATION VXR-LS Laser Film Digitizer Device: 510(k) Number: K974315 Date Received: 11/17/97 Decision Date: 04/17/98 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology Panel Code device classified by: Radiology Product Code: 90 LMA Classification: Class II
Device Description: 21 CFR 807 92(a)(4)
The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.
Indications for Use: 21 CFR 807 92(a)(5)
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
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Image /page/1/Picture/0 description: The image shows the word "RAYPAX" in a stylized font. The "R" is large and bold, while the rest of the letters are smaller and lighter. The letters appear to be slightly faded or textured, giving the image a vintage or worn look.
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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)
"ﺍﻟﺘﻲ ﺗ
The 510(k) Pre-Market Notification for the above referenced device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- RAYPAX™ system has been and will be manufactured in accordance with the 1. voluntary standards listed in the enclosed voluntary standard survey.
- The submission contains the results of a hazard analysis. All potential hazards 3. have been classified as Minor.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Q 1999 SEP
Samsung SDS Co., Ltd. C/o Carl Alletto. Otech, Inc. 2001 East Oakshores Drive Crossroads. Texas 76227
Re:
K992112 Samsung RAYPAX™ Film Digitizer Dated: June 7, 1999 Received: June 22, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Alletto:
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 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 Requlations, 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 vertly such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 (301) 594-4613. 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, "Mistranding 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 (800) 638-2041 or (301) 443-6597, 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: K992112
Device Name:
Samsung SDS Co. Ltd. RAYPAX™ Film Digitizer System
Indications for Use:
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ medical images and data into digital signals. The digital data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
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NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Daniel A. Severson
(Division Sign=Off) Division of Reproductive, Abdominal, ENT, Divisioningical Devi S10(k) Number
(Optional Format 1-2-96)
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§ 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).