(80 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard PACS functionalities like image storage, communication, and display.
No
The device is a Picture Archiving and Communication System (PACS) that processes, stores, and displays medical images and data. It is not described as providing any direct therapeutic intervention or treatment.
No
The device description indicates that iPACS Prism™ is a Picture Archive and Communication System (PACS) that stores, communicates, processes, and displays medical images and data. While it handles medical images, there is no mention of it analyzing or interpreting these images to provide a medical diagnosis or aid in diagnosis. Its function is primarily data management and display.
No
The description indicates a "complete PACS solution" that handles various images and data objects, transmits digital electronic images, and generates reports. While it is software-based, the description of a "system" that includes storage and transmission capabilities suggests it encompasses more than just software and likely includes associated hardware components for these functions. The predicate device is also a PACS system, which typically involves both hardware and software.
Based on the provided information, iPACS Prism™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use and device description of iPACS Prism™ clearly state that it receives, stores, communicates, processes, and displays medical images and data from various imaging sources. It does not involve the analysis of biological samples.
- The focus is on image management and communication. The description highlights its function as a Picture Archive and Communication System (PACS), which is designed for handling and distributing medical images.
Therefore, iPACS Prism™ falls under the category of medical imaging software or a PACS system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Product codes
LLZ
Device Description
iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
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
103 0751
MAY 2 9 2003
Page 1
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: March 2, 2003
Submitter's Information: 21 CFR 807.92(a)(1) RealTimeImage Inc. Zvi Eintracht, CEO 1111 Bayhill Dr. Suite 290 San Bruno, CA 94066
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: iPACS Prism™ bv RealTimeImage Inc. Common Name: Picture Archiving Communications System Device Classification: 892 2050 Name: System, Image Processing
Predicate Device: 21 CFR 807. 92(a)(3)
SYSTEM, IMAGE PROCESSING, Device Classification Name RADIOLOGICAL
| Regulation Number | 892.2050 |
|---|---|
| 510(k) Number | K013630 |
| Device Name | ISITE RADIOLOGY |
| Applicant | STENTOR, INC. |
| 16303 PANORAMIC WAY | |
| SAN LEANDRO, CA 94578 | |
| Product Code | LLZ |
| Date Received | 11/05/2001 |
| Decision Date | 12/05/2001 |
Device Description: 21 CFR 807 92(a)(4)
iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
1
Image /page/1/Picture/0 description: The image shows a square filled with a dot pattern in the upper left corner. Below the square, the word "RealTime" is written in a stylized font. Underneath "RealTime", the word "image" is written in a smaller, dotted font, giving it a faded appearance.
Indications for Use: 21 CFR 807 92(a)(5)
iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. 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 iPACS Prism™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system 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 potential hazards have been classified as Minor.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three horizontal lines extending from its head, resembling feathers or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Real Time Image Inc. c/o Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208
Re: K030751
Trade/Device Name: iPACS Prism" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 9, 2003 Received: March 10, 2003
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 (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.
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.
3
This letter will allow you to begin marketing your device as described in your 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 number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a logo with a square pattern at the top left. Below the pattern, the words "RealTime" are printed in a stylized font. Underneath "RealTime", the word "Image" is printed in a similar font, completing the logo design.
Page 1 of -1
(Indications for Use Form)
Ko30751
510(k) Number:
Device Name:
iPACS Prism™ from Real Time Image Inc.
Indications for Use:
iPACS Prism™ from Real Time Image Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David R. Leggerson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number