(76 days)
Not Found
No
The document describes standard PACS functionalities and image processing techniques like MPR, but there is no mention of AI or ML.
No
The device is a software for viewing and managing medical images; it does not directly treat or diagnose patients.
No
Explanation: The device is a "software device that receives digital images and data" and allows for their "communication, processing, manipulation, enhancement, storage, and display." It functions as a PACS workstation for viewing and managing medical images. While it processes and displays images that may be used for diagnosis by trained professionals, the device itself does not perform the diagnosis. It is a tool that facilitates the diagnostic process rather than making a diagnosis.
Yes
The device is explicitly described as a "software device" in the Intended Use section and the Device Description focuses solely on software functionalities for image processing, display, and management. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PACS CORE/ENCORE™ system is described as a software device that receives, processes, stores, and displays medical images from various imaging modalities (CT, MR, ultrasound, etc.). It also includes features for image manipulation, reporting, and integration with other systems.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens. Its function is centered around the management and display of medical images.
Therefore, the PACS CORE/ENCORE™ 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
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. General features are as follows:
- Integration to PACS systems and inter-connectivity with DICOM stations. ●
- . Performing queries to storage systems in other workstations and/or servers to retrieve DICOM studies or images.
- Image printing in Windows and DICOM printers. ●
- . Selecting and ordering patient lists by date, study, name, gender or ID number.
- Importing and exporting images to DVD or CDROM in the following modes: ● DICOM DIR, DICOM files, JPEG or BMP.
- . Importing NON-DICOM images to DICOM 3.0 format.
- . Transfer of studies, images and reports via e-mail.
- Study Visualization by series.
- Cine feature. ●
- 3D reconstruction allowing: MPR (Multiplane Reconstruction) .
- Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition.
- Possibility to integrate with a Radiology Information System (RIS). ●
- Work list follow-up; dictated study, transcribed study, and authorized study.
- Due to its Web features, it is possible to review, change and approve studies ● remotely.
- . Complete Web Windows Presentation Foundation (XBAP) technology application.
- . Windows Presentation Foundation desk application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F units, computer and 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
Typical users of this system are trained professionals, 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
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data presented in the submission demonstrates that PACS CORE/ENCORE™ performs all required actions according to the functional requirements specified in the SRS and the User Manual with no errors that had an impact on safety or efficacy.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
COMPAÑÍA MEXICANA DE RADIOLOGÍA CGR, S.A. de C.V. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K161518
Trade/Device Name: PACS CORE/ENCORE™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 18, 2016 Received: June 21, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161518
Device Name PACS CORE/ENCORE™
Indications for Use (Describe)
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
May 23, 2016
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Carl Alletto 8317 Belew Drive McKinney TX, 75071 USA Email: carl@otechimq.com Phone: +1 469.684.1980
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | PACS CORE/ENCORE™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K092949 |
| Device Name | IMAGEGRID RADIOLOGY VIEWER SYSTEM |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/24/2009 |
| Decision Date | 10/08/2009 |
| Decision | substantially equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary |
| Type | Traditional |
| Combination Product | No |
Device Description: 21 CFR 807 92(a)(4)
The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. General features are as follows:
- Integration to PACS systems and inter-connectivity with DICOM stations. ●
- . Performing queries to storage systems in other workstations and/or servers to retrieve DICOM studies or images.
4
- Image printing in Windows and DICOM printers. ●
- . Selecting and ordering patient lists by date, study, name, gender or ID number.
- Importing and exporting images to DVD or CDROM in the following modes: ● DICOM DIR, DICOM files, JPEG or BMP.
- . Importing NON-DICOM images to DICOM 3.0 format.
- . Transfer of studies, images and reports via e-mail.
- Study Visualization by series.
- Cine feature. ●
- 3D reconstruction allowing: MPR (Multiplane Reconstruction) .
- Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition.
- Possibility to integrate with a Radiology Information System (RIS). ●
- Work list follow-up; dictated study, transcribed study, and authorized study.
- Due to its Web features, it is possible to review, change and approve studies ● remotely.
- . Complete Web Windows Presentation Foundation (XBAP) technology application.
- . Windows Presentation Foundation desk application.
Indications for Use: 21 CFR 807 92(a)(5)
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems. R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
PACS CORE/ENCORE™ 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.
Testing
5
510(k) Summary of Safety and Effectiveness
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that PACS CORE/ENCORE™ performs all required actions according to the functional requirements specified in the SRS and the User Manual with no errors that had an impact on safety or efficacy.
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification PACS CORE/ENCORE™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. PACS CORE/ENCORE™ 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 "Moderate".