(15 days)
Not Found
No
The document describes a standard PACS system for image storage, communication, and display. There is no mention of AI, ML, or any related technologies, nor are there details about training or test sets which are typical for AI/ML device submissions.
No
The device is a Picture Archiving and Communication System (PACS) that processes and displays medical images and data, rather than directly treating or diagnosing a medical condition.
No
The device is described as a Picture Archive and Communication System (PACS) that handles, stores, communicates, processes, and displays images and data. While it deals with medical images, its function is data management and display, not analysis or interpretation for diagnosis.
Yes
The device description explicitly states it "handles and displays various objects in a Picture Archive and Communication System (PACS) environment" and "transmits digital electronic images and generates reports over a high-speed network." This functionality is entirely software-based, dealing with digital data and communication within a computer system. There is no mention of any hardware components being part of the device itself, only that it receives data from hardware sources.
Based on the provided information, MEDIPACS™ is not an In Vitro Diagnostic (IVD) device.
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 screening. The intended use and device description of MEDIPACS™ clearly state that it receives, stores, processes, and displays digital images and data from various imaging modalities. It does not interact with or analyze biological specimens.
- The focus of MEDIPACS™ is on managing and displaying medical images for diagnostic interpretation by trained professionals. This falls under the category of medical imaging systems and PACS (Picture Archiving and Communication Systems), which are distinct from IVD devices.
Therefore, MEDIPACS™ is a medical imaging and data management system, not an IVD.
N/A
Intended Use / Indications for Use
MEDIPACS™is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MEDIPACS™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. The system transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
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
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 (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
MEDIGAPS
MAR 1 1 2004
K040486
Page 1 of 2
51C(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: December 22, 2003
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Koo Chang Woon Director of R&D NEOBIT Co. Ltd. 7h BITVILLE 1237-33 Seocho-dong Deoch-ku Seoul, 137-072 Korea Tel: 82-2-598-7708 Fax: 82-2-598-7758
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: MEDIPACS™ Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Manufacturer: | Marotech, Inc.
7F Boryung B/D,
66-21 Wonnam-Dong, Jongro-Gu,
Seoul, 110-750, Korea |
|----------------------------------|---------------------------------------------------------------------------------------------|
| 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)
MEDIPACS™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. The system transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
1
Pérez López
Indications for Use: 21 CFR 807 92(a)(5)
MEDIPACS™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). 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 MEDIPACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
MEDIPACS™ 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 have been classified as "minor".
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with its wings spread, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEOBIT Co., Ltd. % Mr. Ned Devine Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548 Re: K040486
Trade/Device Name: MEDIPACSTM System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 25, 2004 Received: February 25, 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
MAR 1 1 2004
3
This letter will allow you to begin marketing your device as described in your Section 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Indications for Use
510(k) Number (if known):
Device Name: MEDIPAC™ System
Indications For Use:
MEDIPACS™is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.).
Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off Division of Reproductive, Abdom and Radiological Devices 510(k) Number