(48 days)
Not Found
No
The document describes a standard PACS system for image storage, communication, processing, and display. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a PACS software system used for managing and displaying medical images, not for direct treatment or therapy.
No
The device is a PACS software for image management and distribution, not for making medical diagnoses. While it handles images that are used for diagnosis, the software itself doesn't perform diagnostic functions.
Yes
The device description explicitly states it is "WEB software based" and "does not require installation of any software and can be operated directly from the browser," indicating it is a software-only solution for PACS functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device receives, stores, communicates, processes, and displays digital images and data from various medical imaging modalities (CT, MR, ultrasound, etc.). This is the core function of a Picture Archiving and Communication System (PACS).
- Device Description: The description reinforces that it's a web-based PACS for image distribution.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens. Its function is solely related to managing and displaying medical images.
The device is a medical imaging software system, specifically a PACS, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Medsynapse PACS Software is a WEB software based 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 he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel 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
Medsynapse is a web PACS, which allows distribution of images within and outside the Hospital using networking technology. It does not require installation of any software and can be operated directly from the browser providing ease of use from anywhere.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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.).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The results of bench testing (software validation and risk analysis) shows that this new device poses no new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.
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
1093247
510(K) Summary K09
DEC - 2 2009
Medsynaptic Private Ltd 47/6, "Vasantika", Opp Yena Bungalow, Paud Road, Kothrud, Pune - 411038, India Tel: 91 - 20 - 25443349 / 25443913 Fax: 91 - 20 - 25443913 URL: http://www.medsynaptic.com Contact: Dr Ashish Dhawad Chief Executive Officer Date prepared: July 23, 2009
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- Trade Name: Medsynapse PACS Software
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- Common Name: PACS Software
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- Classification Name: system, image processing, radiological
- Regulation Description Picture archiving and communications system, product code 4. LLZ, Regulation: 892.2050 Class of device: Class II.
- ട. The legally marketed device to which we are claiming equivalence Voyager PACS System, Voyager Imaging, K062062.
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- Description of device: Medsynapse is a web PACS, which allows distribution of images within and outside the Hospital using networking technology. It does not require installation of any software and can be operated directly from the browser providing ease of use from anywhere.
- Indications for use: Medsynapse PACS Software is a WEB software based device that 7. 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 he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
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- Technological characteristics: The software is installed on a web connected PACS server with the following minimum requirements:
A) Minimal Hardware Requirement
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- Intel Xeon Quad core Processor 3.0 GHz
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- Intel Server Mother Board
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- 4 GB Fully Buffered ECC RAM
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- 1 TB HDD
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- 1GbPS LAN Port
1
B) Minimal Software Requirement
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Windows Server 2003 Standard Edition
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SQL server 2005 Standard Edition
The client computer requires web access using Internet Explorer with the following minimum configuration:
· Pentium IV core 2 duo processor @ 2.8 GHz or faster
· 1 GB of RAM or more
• High speed video graphic card which will support at least 1024x 768 of resolution in 32 bit color
• High resolution monitor with at least 1024 x 768 resolution support in 32 bit color
• MS Windows 2000, XP, 2003, Vista with MS Internet Explorer 6 or higher
Macintosh and other operating systems and internet browsers are not supported at this time
Internet connection: High speed (Broadband) internet connection with at least 512 KbPS of speed, such as wireless, DSL, Cable internet
Performance: The results of bench testing (software validation and risk analysis) shows 9. that this new device poses no new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Medsynaptic Private Ltd. % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114
DEC - 2 2009
Re: K093247
Trade/Device Name: Medsynapse PACS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system . Regulatory Class: II Product Code: LLZ Dated: October 7, 2009 Received: October 15, 2009
Dear Mr. Kamm:
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. Isting 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); medical device reporting of medical
3
Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K09 22 47
Device Name:__Medsynapse PACS Software
Indications For Use:
Medsynapse PACS Software is a web software based 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 he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
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)
Herbert Hoover
Page I of 1
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 09324 510(k) Number _