(42 days)
Not Found
No
The summary describes a PACS-like software for image viewing, reporting, and management, with no mention of AI or ML capabilities.
No
The device is described as software for viewing and interpreting medical images for diagnostic purposes, and for managing patient records and reports. It does not perform any therapeutic function or directly treat any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems." This indicates its role in the diagnostic process.
Yes
The device is described as a "software application" and its functions are entirely software-based, focusing on image viewing, manipulation, reporting, and data management. While it requires "suitable commercial standard hardware" for installation, the device itself is the software component.
Based on the provided information, the iMagic v2.0™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- iMagic v2.0™ function: The iMagic v2.0™ device is software intended for the viewing and diagnostic interpretation of medical images acquired from various imaging modalities (Ultrasound, CT, MR, CR, DR). It processes and displays images, manages patient records, and generates reports.
- No analysis of biological samples: The device does not perform any tests or analysis on biological samples from the patient. Its function is centered around the handling and interpretation of medical images.
Therefore, based on the intended use and device description, iMagic v2.0™ falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
iMagic v2.0™ device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.
iMagic v2.0™ receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0™ does not use lossy (irreversible) compression during image handling, manipulation, or storage.
Only DICOM, for presentation, images will be captured for display and diagnosis.
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.
Product codes
LLZ
Device Description
iMagic, a software application for medical imaging centers, that allows to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email). Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:
- . Prevent unauthorized access of Patient Records
- Easy search of Patient details .
- . Flexibility to design auto patient ID
- Report transmission by mail .
- . Cropping of live images
- Editing of AVI/cine loops
- Distribution of Reports and Images in CD .
- . Comparison of images between different visits of patient
- . Tagging of significant images/cineloops for future references
- . Generation of statistical data from available details
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR)
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)
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).
0
l
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: May 19, 2007
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sunder Natrajan, CEO Ashva Technologies Pvt. Ltd., 15 ARK Colony, Urrnilla House Eldams RD. Alwarpet, Chennai India 600018 +11 91 44 420 88897 (fax) sunder@ashvatech.com
JUL 2 3 2007
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | iMagic v2.0™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Device Classification: | 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
| iMagic v2.0™ is substantially equivalent to: | |
|---|---|
| Manufacturer: | Voyager Imaging |
| Device Name: | Voyager PACS Stystem |
| 510(k) Number: | K062062 |
| Product Code: | LLZ |
| Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| Regulation Number: | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
iMagic, a software application for medical imaging centers, that allows to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email). Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:
- . Prevent unauthorized access of Patient Records
- Easy search of Patient details .
- . Flexibility to design auto patient ID
- Report transmission by mail .
- . Cropping of live images
1
- Editing of AVI/cine loops �
- Distribution of Reports and Images in CD .
- . Comparison of images between different visits of patient
- . Tagging of significant images/cineloops for future references
- . Generation of statistical data from available details
Indications for Use: 21 CFR 807 92(a)(5)
iMagic v2.0™ device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.
iMagic v2.0™ receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0™ does not use lossy (irreversible) compression during image handling, manipulation, or storage.
Only DICOM, for presentation, images will be captured for display and diagnosis.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images mav 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.
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 iMagic v2.0™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
iMagic v2.0™ 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".
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 3 2007
Ashva Technologies, Pvt. Ltd. c/o Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K071602
Trade/Device Name: iMagic v2.0TM Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2007 Received: June 11, 2007
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in it. The logo has a star at the top and three stars at the bottom. The text is arranged in a circular fashion around the central FDA logo.
3
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.
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 mumber at the top of this letter.
21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other
240-276-0115 (Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) 240-276-0115 (Radiology) 240-276-0120 240-276-0100
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
(Indications for Use Form)
510(k) Number:
Device Name:
iMagic v2.0
Indications for Use:
iMagic v2.0™ device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.
iMagic v2.0™ receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0™ does not use lossy (irreversible) compression during image handling, manipulation, or storage.
Only DICOM, for presentation, images will be captured for display and diagnosis.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| --------------------------------------------------------------------------------------------------- | -------- | ------------------------------------------------------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | 2071602 |
|---|---|
| --------------- | --------------------------------------------------------- |