(86 days)
No
The document describes a standard PACS system for image management and distribution, with no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a system for receiving, storing, communicating, processing, and displaying digital medical images and data. Its function is to manage medical images, not to directly treat or diagnose a medical condition.
No
The device description indicates that PACSPLUS™ is a system for capturing, storing, distributing, and networking medical images. It does not perform any analysis or interpretation of images to provide a medical diagnosis.
No
The device description explicitly mentions acquiring medical images using a DICOM gateway and film digitizers, which are hardware components. While the core functionality is software-based (storage, communication, processing, display), the system relies on and integrates with hardware for image acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use and device description of PACSPLUS™ clearly state that it deals with medical images from various imaging modalities (CT, MR, ultrasound, etc.).
- The purpose of PACSPLUS™ is to manage, store, transmit, and display these images. It does not perform any analysis or testing on biological samples.
Therefore, PACSPLUS™ falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PACSPLUS™ is a device 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.
Product codes
LLZ
Device Description
PACSPLUS™ 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™, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the words "MEDICAL STANDARD" in a stylized font. To the left of the words is a black logo that looks like a square with three lines coming out of the top left corner. The words are in all caps and are slightly spaced out. The image is in black and white.
Image /page/0/Picture/1 description: The image shows the word "PACSPLUS" in bold, black letters. Below the word "PACSPLUS" is the phrase "Best Image Quality" in a smaller font. The text is all in black and is set against a white background.
510(k) Summary of Safety and Effectiveness
KOJ460
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: October 10, 2002
Submitter's Information: 21 CFR 807.92(a)(1)
Medical Standard Co. Ltd., Hanyang Institute of Technology 17, Haengdang-dong Sungdong-ku Seoul, Korea, 133-791
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
Trade Name: Common Name: Device Classification: Name:
PACSPLUS™ Picture Archiving Communications System 892.2050 System, Image Processing
Predicate Device: 21 CFR 807. 92(a)(3)
| Manufacturer: | MAROTECH, INC
66-21 Wonnam-Dong, Jongro-Gu, |
|--------------------------------------------|--------------------------------------------------------------------|
| | Seoul, 110-750, Korea |
| Device: | MAROSIS™ PACS |
| 510(k) Number: | K012844 |
| Decision Date: | 11/08/2001 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: Radiology | |
| Panel Code device classified by: Radiology | |
| Product Code: | LLZ |
| | Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
PACSPLUS™ 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™, 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.
JAN 0 9 2003
1
Image /page/1/Picture/0 description: The image shows the words "MEDICAL STANDARD" in a stylized font. To the left of the words is a black graphic that looks like a stylized medical symbol. The text is in all caps and appears to be part of a logo or heading. The image is in black and white.
Image /page/1/Picture/1 description: The image shows the logo for PACSPLUS. The text is in bold, black font. Underneath the main text, it says "Best Image Quality" in a smaller font.
Indications for Use: 21 CFR 807 92(a)(5)
PACSPLUS™ is a device 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.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and 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 displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for PACSPLUS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
PACSPLUS™ device 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".
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. YoungJin Hong Technical Manager Medical Standard Co., Ltd. Hanyang Institute of Technology 17, Haengdang-dong Sungdong-ku 133-791 SEOUL KOREA
JAN 0 9 2003
Re: K023460
Trade/Device Name: PACSPLUSTM System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2002 Received: October 15, 2002
Dear Mr. Hong:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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, "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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(Indications for Use Form)
KO23460 510(k) Number:
Device Name:
PACSPLUS™ system by Medical Standard Co. Ltd.
Indications for Use:
PACSPLUS™ is a device 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.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __