(14 days)
Not Found
No
The document describes a standard PACS system for image management and distribution, with no mention of AI or ML capabilities.
No.
The device is described as software for managing and displaying medical images, not for treating any medical condition or directly providing therapy.
No
The device is described as software that receives, stores, communicates, processes, and displays digital images and data for review and telecommunications. While it handles medical images, its function is data management and display, not the direct diagnosis of a condition. Diagnostic devices typically analyze data to produce a medical conclusion or aid in diagnosis, which is not the primary function described here.
Yes
The device description and intended use clearly define PACSPartner™ as software that handles digital images and data from various sources, focusing on capturing, storage, viewing, distribution, and networking. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- This device, PACSPartner™, deals with medical images (CT, MR, ultrasound, etc.) and associated data. It's a system for capturing, storing, viewing, and distributing these images.
- The intended use and device description clearly focus on image management and display, not on analyzing biological samples.
Therefore, PACSPartner™ falls under the category of medical imaging software or a PACS (Picture Archiving and Communication System), not an IVD.
N/A
Intended Use / Indications for Use
PACSPartner™ is software 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.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
PACSPartner™ makes possible the capturing, storage, viewing, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, 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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
K04 2311
Image /page/0/Picture/1 description: The image shows the word "PACS" in large white letters on a black background. To the right of "PACS" is the website address "www.pacspartner.com" in a smaller font, also in white. The overall design is simple and clean, with a focus on the company name and its online presence.
SEP = 9 2004
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: August 2, 2004
Submitter's Information: 21 CFR 807.92(a)(1) YoungJin Hong Technical Manager 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) PACSPartner™ Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiologica |
|---|---|
| 510(k) Number | K023460 |
| Regulation Number | 892.2050 Class II |
| Device Name | PACSPlus™ |
| Applicant | Medical Standard Co. Ltd., |
| Product Code | LLZ |
| Decision Date | 01/09/2003 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
PACSPartner™ makes possible the capturing, storage, viewing, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, 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.
Indications for Use: 21 CFR 807 92(a)(5)
PACSPartner™ is software 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
1
Image /page/1/Picture/0 description: The image shows the word "PACS" in white font on a black background. To the right of the word "PACS" is the website address "www.pacspartner.com", also in white font. The font appears to be slightly pixelated. The image is simple and contains only text.
and or across computer networks at distributed locations. Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA Typical users of this system are trained professionals, physicians, nurses, and technicians.
Technological Charácteristics: 21 CFR 807 92(a)(6)
PACSPartner™ is a software product that handles digital mages. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for PACSPartner™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
PACSPartner™ 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/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
Medical Standard Co., Ltd. % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548
Re: K042311
Trade/Device Name: PACSPartnerTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: August 24, 2004 Received: August 26, 2004
Dear Mr. Devine:
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 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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you to organization of substantial equivalence of your device to a legally premarket noticate 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 If you desire specific advise at one of the following numbers, based on the regulation number at the top of the 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 Additionally, 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Complianoo at (2017 oration" (21CFR Part 807.97) you may obtain. Other general of reference to promation in the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or Hanafabrer of Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(Indications for Use Form)
K042311 510(k) Number:
Device Name:
PACSPartner™ software by Medical Standard Co. Ltd.
Indications for Use:
PACSPartner™ is software 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.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
AD/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lepson
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number _