(18 days)
Not Found
No
The document describes a standard PACS system for image storage, retrieval, and viewing. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies. The performance studies focus on DICOM compliance and software validation, not AI/ML performance metrics.
No
The device is a Dicom PACS software that receives, stores, communicates, processes, and displays digital images and data for medical image management, not for directly treating a disease or condition.
Yes
The device is a Picture Archiving and Communication System (PACS) that receives, stores, communicates, processes, and displays medical images and data from various imaging modalities. These images are used by medical professionals for primary image interpretation, which is a key component of diagnosing medical conditions.
Yes
The device description explicitly states "CuriePACS (Dicom PACS Software) Software is a software device" and details its components as a "Dicom Server" and "Image Viewer," both described as software functionalities. While it interacts with hardware (modalities and monitors), the device itself, as described, is the software system for managing and viewing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for receiving, storing, communicating, processing, and displaying medical images from various imaging modalities (CR, MRI, CT, etc.). This is the core function of a PACS (Picture Archiving and Communication System).
- Device Description: The description reinforces that it's a PACS solution with a Dicom Server and Image Viewer for handling medical images.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. This device does not interact with or analyze biological specimens. Its function is solely related to medical imaging data.
Therefore, CuriePACS is a medical imaging software device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). 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
LLZ
Device Description
CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, DX, MG, MR, NM, RF, SC, US, XA, ES (Endoscopy)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals, WEB based
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 nonclinical tests submitted showing Dicom 3 compliance, along with bench testing (software validation and risk analysis) shows that this new device has equivalent indications and performs in an equivalent fashion to the named predicate. Therefore this device poses no new issues of safety or effectiveness, and is substantially equivalent to the predicate device.
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).
0
510(K) Summary K102148
Moksha Digital Software PVT Limited #1611, Janardhana Towers, 7th Cross, 19th Main, Sector 1, HSR Layout, Bangalore 560034, India Phone : +91 (80) 4110 1208 Fax : +91 (80) 4110 1824 E-mail : sales@mokshadigital.com Contact: Deepak Sharma, Managing Director Date prepared: August 12, 2010
AUG 1 7 2010
- 1 . Trade Name: CuriePACS Dicom PACS Software Common Name: PACS Software Classification Name: System, image processing, radiological
-
- Regulation Description Picture archiving and communications system, product code LLZ, Regulation: 892.2050 Class of device: Class II.
-
- The legally marketed device to which we are claiming equivalence Voyager PACS System, Voyager Imaging, K062062.
-
- Description of device: CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.
- న. Indications for use: CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). 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.
- Technological characteristics: The software is installed on a network connected PACS server 6. with the following minimum requirements:
- Microsoft® Windows® XP Service Pack 2 or above .
- Microsoft® Windows® Vista Service Pack 1 or above .
- . Microsoft .Net Framework 3.5 SP1
- Microsoft Internet Explorer 7 or above .
- Intel Core 2 Duo Processor .
- 320 GB HDD .
1
- 2 GB RAM (Min) •
- Dedicated or Onboard Graphics card with minimum 1440 x 900 resolution and DVI output. •
- . Gigabit Ethernet Adaptor
- . Display: The display used for diagnosis purposes should be FDA approved self calibrating medical grade monitor which is driven by a digital input (DVI output from graphics card).
| Characteristic | Predicate Device
Voyager PACS System, Voyager
Imaging, K062062 | CuriePACS (Dicom PACS Software)
(This submission) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Voyager PACS System is a 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 dev ices, 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.
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 approved monitor that offers at
least 5 Mpixel resolution and meets other
technical specifications reviewed and accepted
by FDA. | CuriePACS (Dicom PACS Software) Software
is a software device that receives digital
images and data from various sources
(Computed Radiography, Magnetic Resonance
Imaging, Ultrasound, Endoscopy, Computed
Tomography, Digital X-Ray Mammography,
Nuclear Medicine Imaging, Secondary
Capture, Radio Fluoroscopy, X-Ray or other
Angiograms such as CT Angio). Images and
data can be 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. |
| Use, key feature
Connection | Medical professionals, WEB based
WEB and Ethernet | SAME |
| Multimodality
Connectivity,
DICOM
compatibility | Voyager PACS can receive with ease
any DICOM compliant image,
irrespective of the source | Connect all DICOM Modalities CR,
CT, DX, MG, MR, NM, RF, SC,
US, XA (x-ray), and ES. |
| Image Sources | Dicom, JPEG and JPEG 2000 compliant | SAME |
| Target hardware | PC compatible | SAME |
| Image Processing
Tools | • Brightness/ Contrast
• Mouse button operation for quick
image manipulation • Selectable
multiple image view• Magnify, zoom
and pan• Flip (left/ right, top/bottom)
and rotate• Image inversion
• Measurement and angles | All processing tools Stack,
Window/Level, Zoom, Pan,
Magnifying Glass, Probe, Spatial
Locator, Draw Shutter, Ruler,
Elliptical ROI, Rectangular ROI,
Polygonal ROI, Text Area, Text
Callout, Protractor. |
| Security | SSL Encryption | SAME |
7. Comparison Table
Performance: The results of nonclinical tests submitted showing Dicom 3 compliance, 8. along with bench testing (software validation and risk analysis) shows that this new device has equivalent indications and performs in an equivalent fashion to the named predicate. Therefore this device poses no new issues of safety or effectiveness, and is 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
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
Moksha Digital Software PVT Limited % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
AUG 1 7 2010
Re: K102148
Trade/Device Name: CuriePACS (Dicom PACS Software) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: July 29, 2010 Received: July 30, 2010
Dear Mr. Job:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
Enclosure
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K102148.
Device Name: CuriePACS (Dicom PACS Software)
Indications For Use:
CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). 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 In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
510K K102148