(14 days)
No
The summary describes a standard PACS/image viewing software with basic image manipulation features and network capabilities. There is no mention of AI, ML, or any advanced analytical functions that would typically indicate the presence of such technology.
No.
The device is a software for viewing and manipulating medical images, not for treating or diagnosing medical conditions.
No.
The device is a software for viewing and manipulating images for display, processing, storage, and communication, not for rendering a medical diagnosis itself.
Yes
The device is explicitly described as a "software device" and its components (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) are all software applications. While it interacts with hardware (modalities, servers, workstations), the device itself is the software suite.
Based on the provided information, this 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- InstaRad's Function: InstaRad is a software device used for viewing, manipulating, storing, and communicating medical images acquired from various imaging modalities (CT, MR, X-ray, etc.). It deals with visual representations of the body's internal structures, not with analyzing biological samples.
- Intended Use: The intended use clearly states it's for "viewing and manipulating medical images." This aligns with image management and display, not diagnostic testing of biological samples.
- Device Description: The description reinforces its function as an image management and viewing system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical or biological tests, or providing diagnostic information based on laboratory analysis.
Therefore, InstaRad falls under the category of medical image management and viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InstaRad™ is a software device (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records.
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
InstaRad™ is an application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, InstaRad™ can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
InstaRad™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:
- DICOM Gateway Application is deployed at all remote centre or . hospitals. It receives images from modalities over LAN and uploads them to central server.
- Central Server runs the Web Server and Image Server and provide . study and image data to doctors.
- . WorkStation - Doctor at client side access the study list in the browser. They can select the patient and download the images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists (Physician)
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
FEB 2 1 2008
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:
January 2, 2008
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Nishant Mitta! Co-Founder and Director, R&D MedSphere Technologies Pvt. Ltd. GF, B-18, 2nd Main, KEB Layout, BTM 1st Stage Bangalore, Karnataka, India - 560 076 Tel: +91-80-64514222126684959 Fax: +91-80-26684959
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | InstaRad™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
InstaRad™ is substantially equivalent to:
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K062490 |
| Device Name | VISAGE PACS/CS, RELEASE VERSION 4.1 |
| Applicant | MERCURY COMPUTER SYSTEMS, INC |
| 199 Riverneck Road, | |
| Chelmsford, MA 01824 | |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 08/31/2006 |
| Decision Date | 10/27/2006 |
| Decision | substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
InstaRad™ is an application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing
1
510(k) Summary of Safety and Effectiveness
images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, InstaRad™ can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
InstaRad™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:
- DICOM Gateway Application is deployed at all remote centre or . hospitals. It receives images from modalities over LAN and uploads them to central server.
- Central Server runs the Web Server and Image Server and provide . study and image data to doctors.
- . WorkStation - Doctor at client side access the study list in the browser. They can select the patient and download the images.
Indications for Use: 21 CFR 807 92(a)(5)
InstaRad™ is a software device (DICOM Gateway Application, InstaRad™ Enterprise Server, and Client Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. 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.
Technological Characteristics: 21 CFR 807 92(a)(6)
InstaRad™ device is a software product that handles digital medical images. 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 InstaRad™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
InstaRad™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".
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines extending from its back, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 21 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medsphere Technologies Pvt. Ltd. c/o Mr. Ned Devine Sr. Staff Engineer and Reviewer Underwriters Laboratories. Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096
K080334 Re:
Trade/Device Name: InstaRad" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 30, 2008 Received: February 7, 2008
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 Rederal Register.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
K080334 510(k) Number (if known):
Device Name: InstaRad™
Indications for Use:
InstaRad™ is a software device (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records.
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Division of Reproductive, Abdominal and . Radiological Devices 510(k) Number