(53 days)
Not Found
No
The document describes a standard PACS system for image storage, management, and distribution. There is no mention of AI, ML, or any related technologies in the device description, intended use, or other sections. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is described as a PACS system designed for storing, communicating, processing, and displaying medical images and data. It does not actively treat or diagnose medical conditions, which are characteristics of therapeutic devices.
No
This device is a PACS system that receives, stores, processes, and displays medical images and data, but it does not perform diagnostic functions itself. It is a tool for managing and viewing diagnostic images, not a diagnostic device.
Yes
The device description explicitly states "Voyager PACS System™ is a software based device" and describes its functions as receiving, capturing, storing, communicating, processing, and displaying digital images and data. While it interacts with hardware (scanners, monitors, servers, workstations), the device itself, as described, is the software system managing these interactions and data.
Based on the provided information, the Voyager PACS System™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Voyager PACS Function: The description clearly states that the Voyager PACS System™ receives, stores, communicates, processes, and displays digital images and data from various imaging modalities (CT, MR, ultrasound, etc.). It is a system for managing and viewing medical images.
- No Specimen Analysis: There is no mention of the device analyzing biological specimens or providing diagnostic information based on such analysis. Its function is centered around the handling of medical images.
Therefore, the Voyager PACS System™ falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Voyager PACS System™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, 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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Voyager PACS is a web enabled PACS system that provides medical images of any patient to any doctor, anytime, anywhere. Voyager PACS is a server based system that allows image archiving, storage, management and distribution. The system receives images from Modalities via DICOM or from other sources (i.e. Teleradiology). Images are stored on the PACS Server. The studies and images on this server can be viewed, reported and manipulated by the Voyager Diagnostic workstations connected to the PACS server via LAN, WAN or Internet connection. Voyager Integrator provides seamless interface to the Radiology Information System (RIS) via HL7, allowing information between the Voyager PACS and the RIS to be shared and exchanged. General Features and Benefits of Voyager PACS
- Centralized or Distributed Archive functionality .
- Uses commercially available computers, servers, operating systems and . network infrastructure, with expandable storage capability
- . Single or Multi server options (i.e. Archive, Web Server and PACS broker can reside on a single server computer)
- Preemptive downloading prefetching of images in real time .
- . Web based solution
- Scalable from single practice to enterprise wide PACS .
- . High level of security
- DICOM, JPEG and JPEG 2000 compliant .
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, etc.
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): 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
Koc2012
510(k) Summary of Safety and Effectiveness
SEP 1 1 2006
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: July 15, 2006
Submitter's Information: 21 CFR 807.92(a)(1)
Lance P. Thomas Business Development Manager Voyager Imaging (a division of Intellirad Solutions Pty Ltd) Level 1, 123 Camberwell Rd East Hawthorn VIC 3123 Australia Phone: (03) 9811 9901
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
Trade Name: | Voyager PACS System ™ |
---|---|
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)
Voyager PACS System is substantially equivalent to: | |
---|---|
Manufacturer: | S.C. INFO WORLD S.R.L. |
Device Name: | IQPACS |
510(k) Number: | K060263 |
Decision Date: | 03/15/2006 |
Decision: | Substantially Equivalent |
Product Code: | LLZ |
Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
Regulation Number: | Class II - 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
Voyager PACS is a web enabled PACS system that provides medical images of any patient to any doctor, anytime, anywhere. Voyager PACS is a server based system that allows image archiving, storage, management and distribution. The system receives images from Modalities via DICOM or from other sources (i.e. Teleradiology). Images are stored on the PACS Server. The studies and images on this server can be viewed, reported and manipulated by the Voyager Diagnostic workstations connected to the PACS server via LAN, WAN or Internet connection. Voyager Integrator provides seamless interface to the Radiology Information System (RIS) via HL7, allowing information between the Voyager PACS and the RIS to be shared and exchanged. General Features and Benefits of Voyager PACS
1
- Centralized or Distributed Archive functionality .
- Uses commercially available computers, servers, operating systems and . network infrastructure, with expandable storage capability
- . Single or Multi server options (i.e. Archive, Web Server and PACS broker can reside on a single server computer)
- Preemptive downloading prefetching of images in real time .
- . Web based solution
- Scalable from single practice to enterprise wide PACS .
- . High level of security
- DICOM, JPEG and JPEG 2000 compliant .
Indications for Use: 21 CFR 807 92(a)(5)
Voyager PACS System™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured. 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)
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 Voyager PACS System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Voyager PACS 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 "Level of Concern for potential hazards has been classified as "minor".
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP | 1 2006
Voyager Imaging c/o Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K062062
Trade/Device Name: Voyager PACS System™ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2006 Received: July 24, 2006
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 for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a bold, stylized font, with the word "Centennial" written below. Three stars are placed beneath the word "Centennial". The logo is surrounded by text that follows the circular shape.
Protecting and Promoting Public Health
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be act note a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I 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 CI IT rat 607); adoning (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic form in the quality bytellio (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) This letter with and in Jourse FDA finding of substantial equivalence of your device to a legally premated predicated. " 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 11 you a ten Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
---|---|---|
21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
21 CFR 894.xxx | (Radiology) | 240-276-0120 |
Other | 240-276-0100 |
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/cdrl/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: Kø6 Z o 62
Device Name: Voyager PACS System™
Indications for Use:
Voyager PACS System™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices. scanners. imaging gateways, etc.).
Images and data can be captured. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K162062