(42 days)
Not Found
No
The document describes a standard PACS/RIS system for image viewing, storage, and communication. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image manipulation (window/level, annotation). The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No.
This device is a software for viewing and manipulating medical images, not for treating or diagnosing medical conditions.
No
The device is described as a software device used for viewing, manipulating, processing, storing, and communicating digital medical images from various sources (e.g., CT, MR). Its primary function is to facilitate image management and access for radiologists and clinicians, not to perform diagnosis itself. It integrates with existing information systems and allows image adjustments but does not provide diagnostic interpretations or findings. The phrase "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation" further indicates it's not for direct diagnostic interpretation, especially for critical cases like mammography without an FDA-approved monitor.
Yes
The device description explicitly states that InstaPACS™/InstaRISPACS™ is a "software device" and a "software application." While it interacts with hardware (servers, workstations, imaging modalities), the device itself, as described, is the software component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device processes medical images: The description clearly states that InstaPACS™/InstaRISPACS™ is a software device used for "viewing and manipulating digital medical images" from various imaging modalities (CT, MR, US, etc.). It does not analyze biological samples.
- The intended use is image management and viewing: The intended use focuses on displaying, processing, storing, and communicating medical images for interpretation by radiologists and clinicians.
Therefore, while it is a medical device, it falls under the category of medical image management and viewing software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital 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. InstaPACS™/instaRISPACS™ 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
InstaPACS™/InstaRISPACS™ is a software 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, the device can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study), providing seamless access to reports for fully-integrated electronic patient records.
InstaPACS™/InstaRISPACS™ 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:
- . Central Server - runs the Web Server and Image Server and provide study and image data to doctors. The server includes a DICOM Gateway Application which is deployed at remote centers or hospitals. It receives images from modalities over LAN and uploads them to central server
- WorkStation User at the client side can 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, mammography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Clinicians and referring Physicians
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 complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the InstaPACS™InstaRISPACS ™ software in each operational mode and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
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
510(k) Summary of Safety
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
February 19, 2012
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Sanieev. MD and CEO MEDDIFF Technologies Pvt. Ltd. Salarpuria Palladium, 3rd floor, #2021. 100 ft Road. HAL 2ndStage Bangalore - 560 008, Karnataka - India Tel: +91-80-65350192 Fax: +91-80-66885510
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
- Trade Name: Common Name: Device Classification: Product Code:
InstaPACS™/InstaRISPACS™ Picture Archiving Communications System 892.2050 System, Image Processing LLZ
Predicate Device: 21 CFR 807. 92(a)(3)
InstaPACS™/InstaRISPACS™ is substantially equivalent to:
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K080334 |
| Device Name | InstaRAD |
| Applicant | MEDSPHERE TECHNOLOGIES PVT LTD. |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Decision Date | 02/21/2008 |
| Decision | substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
InstaPACS™/InstaRISPACS™ is a software 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
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manipulations. In addition, the device can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study), providing seamless access to reports for fully-integrated electronic patient records.
InstaPACS™/InstaRISPACS™ 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:
- . Central Server - runs the Web Server and Image Server and provide study and image data to doctors. The server includes a DICOM Gateway Application which is deployed at remote centers or hospitals. It receives images from modalities over LAN and uploads them to central server
- WorkStation User at the client side can 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)
InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital 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. InstaPACS™/instaRISPACS™ 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 fullyintegrated 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)
InstaPACS™/InstaRISPACS ™ 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. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the InstaPACS™InstaRISPACS ™ software in each operational mode and followed the process documented in the System Validation Test Plan.
2
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for InstaPACS™/InstaRISPACS ™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Therefore, InstaPACS™/InstaRISPACS™ is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three distinct wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
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
MEDDIFF Technologies Pvt. Ltd. % Mr. Carl Alletto Official Correspondent 1600 Manchester Way CORINTH TX 76210
Re: K120718
Trade/Device Name: InstaPACSTM/InstaRISPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2012 Received: April 12, 2012
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 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
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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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
InstaPACS™/InstaRISPACS™
Indications for Use:
InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital 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. InstaPACS™InstaRISPACS™ 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 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) (Division Sign-Off) Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K120718
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