(15 days)
Not Found
No
The summary describes a standard PACS system for storing, communicating, processing, and displaying medical images. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic image processing and display.
No
The device is a PACS solution for managing and displaying medical images, not a device that directly treats or diagnoses a medical condition.
No
The device is a Picture Archiving and Communication System (PACS) solution that stores, communicates, processes, and displays medical images and data. It is explicitly stated that lossy compressed mammographic images and digitized film screen images "must not be reviewed for primary image interpretation," indicating it is not intended for primary diagnostic interpretation. While it handles images used for diagnosis, the device itself is a tool for managing and viewing these images, and not for making a diagnosis.
Yes
The device is explicitly described as a "software device and server" and a "client/server software application and server." While it interacts with hardware (imaging sources, monitors), the device itself, as described, is the software and the server component, not the physical imaging hardware or display hardware.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that ImageGrid™ is a software device and server that receives, stores, communicates, processes, and displays digital images from various medical imaging modalities (CT, MR, ultrasound, etc.). It is a PACS (Picture Archiving and Communication System) solution.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is solely related to the management and display of medical images.
Therefore, ImageGrid™ falls under the category of medical imaging software and not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be 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.
Product codes
LLZ
Device Description
ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record.
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources.
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
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:
December 24, 2007
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Mel Sharperson Management Representative Candelis Inc. 18821 Bardeen Ave. Irvine, CA 92612 Tel: 949-852-1000 Fax: 949-752-7317 Email: mel.sharperson@candelis.com
2
Trade Name, Common Name and Classification: 21 CFR 807.92(a){2} Trade Name: ImageGrid™
| Trade Name: | ImageGrid |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number: | K012211 | K052358 |
|---|---|---|
| Manufacturer: | EFILM MEDICAL, INC | ETIAM, S.A. |
| Device Name: | EFILM WORKSTATION | ETIAM STAR PACS |
| COMPONENTS | ||
| Decision Date | 07/31/2001 | 10/05/2005 |
| Product Code: | LLZ | LLZ |
| Device Classification | ||
| Name: | SYSTEM, IMAGE | |
| PROCESSING, | ||
| RADIOLOGICAL | SYSTEM, IMAGE | |
| PROCESSING, | ||
| RADIOLOGICAL | ||
| Regulation Number: | Class II - 892.2050 | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record.
Indications for Use: 21 CFR 807 92(a)(5)
1
510(k) Summary of Safety and Effectiveness
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be 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.
Technological Characteristics: 21 CFR 807 92(a)(6)
lmageGrid™ device is a 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 ImageGrid™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
ImageGrid™e 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
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's head, body, and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
MAR 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candelis, Incorporated % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062-2096
Re: K080333
Trade/Device Name: ImageGrid™M Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 31, 2008 Received: February 7, 2008
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of February 22, 2008.
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 (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 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.
3
Page 2 - Mr. Ned Devine
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 (OS) 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 continue 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Jorgi M. Whing
Gr 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
510(k) Number (if known):
K08033
Device Name: ImageGrid™
Indications for Use:
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be 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.
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)
Arnie B. Whing
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number