(58 days)
Not Found
No
The document describes a standard PACS system for image management and display, with no mention of AI, ML, or related concepts like image analysis or interpretation beyond basic manipulation and display.
No
The device is intended for the manipulation, management, and display of medical images, focusing on image handling and distribution within a PACS environment, rather than providing direct therapeutic treatment or diagnosis.
No
The device is described as manipulating, managing, and displaying medical images, not identifying disease or making a diagnosis. Its function is to facilitate image management and distribution.
Yes
The device description explicitly states that SmartPACS™ is a "server-based software application" and a "distributed image management system." It manages and displays images from various modalities and interfaces, distributing them using DICOM standards. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the SmartPACS™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "manipulation, management, and display of medical images." This involves handling and presenting images generated by other medical devices (like CT, MR, CR systems). It does not involve analyzing biological samples or providing diagnostic information based on in vitro testing.
- Device Description: The description focuses on the software's function as an image management system within a PACS environment. It handles archival, retrieval, and distribution of images and related data. This is consistent with a medical image management system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic results based on laboratory tests. The input is medical images, not biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SmartPACS™ device's function is entirely focused on managing and displaying images generated by other medical imaging modalities.
N/A
Intended Use / Indications for Use
The SmartPACS™ device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Product codes
LLZ
Device Description
The SmartPACS™ system is a server-based software application.
Smart PACS (SP) is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment.
The SP system provides online access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians.
The SP system implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOMcompliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
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)
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/1 description: The image shows a logo with the text "TEDPC" in a bold, stylized font. The letters are connected and have a slightly futuristic or technical appearance. Above the letters, there is a series of short, parallel lines that resemble a stylized representation of a circuit board or some other technological element. The logo is in black and white, with the letters and lines appearing in solid black against a white background.
Taiwan Electronic Data Processing Corporation
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 8, 2002
Submitter's Information: 21 CFR 807.92(a)(1) Taiwan Electronic Data Processing Corporation 3rd Floor, No. 2, Lane 7, Pao-Kuo Road Hsin-Tien City, Taipei Hsien Taiwan, Republic of China
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: SMARTPACS™ 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, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K002936 |
| Device Name | MODIFICATION TO IDS5 IMAGE DISPLAY |
| SYSTEM | |
| Applicant | SECTRA-IMTEC AB |
| Product Code | LLZ |
| Date Received | 09/21/2000 |
| Decision Date | 10/17/2000 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
Device Description: 21 CFR 807 92(a)(4)
The SmartPACS™ system is a server-based software application.
Smart PACS (SP) is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment.
The SP system provides online access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians.
l
1
Image /page/1/Picture/0 description: The image shows a logo with the text "TEDPYC" in a bold, sans-serif font. The letters are black and appear to be slightly distressed or textured. Above the "PYC" portion of the text, there is a stylized graphic element that resembles a series of connected lines or a simplified representation of a circuit. The overall impression is that of a brand or organization with a modern, possibly technical, focus.
The SP system implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOMcompliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
Indications for Use: 21 CFR 807 92(a)(5)
The SmartPACS™ device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is a software server application and 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 SmartPACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device SmartPACS™ 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 potential hazards have been classified as Minor.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three curved lines that resemble the wings of a bird or the branches of a tree. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2002
Taiwan Electronic Data Processing Corporation % Mr. Carl Alletto 1100 Lakeview Blvd. DENTON TX 76208
Re: K022710
Trade/Device Name: SmartPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: July 22, 2002 Received: August 14, 2002
Dear Mr. Alletto:
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 (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 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a black and white graphic of the word "TEDPC" in a stylized font. The letters are bold and have a slightly distressed appearance, as if they were stamped or printed with a worn-out ink. The overall impression is that of a logo or a brand name.
Taiwan Electronic Data Processing Corporat
Page 1 of -1
(Indications for Use Form)
Ko22710 510(k) Number:
Device Name: SmartPACS™ system
Indications for Use:
The SmartPACS™ device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
(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 A. Seymann