PACS CORE/ENCORE

K161518 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · LLZ · Aug 17, 2016 · Radiology

Device Facts

• Record ID: K161518
• Device Name: PACS CORE/ENCORE
• Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
• Product Code: LLZ · Radiology
• Decision Date: Aug 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

PACS CORE/ENCORE™ is a software-based PACS workstation for medical imaging. It receives DICOM 3.1 images from modalities like CT, MR, ultrasound, and R/F units. The system enables remote review, modification, and approval of studies via web-based (XBAP) and desktop Windows Presentation Foundation applications. Key features include DICOM/non-DICOM image import/export, cine playback, Multi Planar Reconstruction (MPR), and integration with RIS for reporting via templates and voice recognition. Used by physicians, nurses, and technicians in clinical settings, the device facilitates study management, printing, and distribution. By providing centralized access to images and tools for manipulation and reporting, it supports clinical decision-making and workflow efficiency. It does not contact patients or control life-sustaining equipment; human intervention is required for all interpretations.

Clinical Evidence

Bench testing only. The system underwent factory-level testing against pre-determined functional requirements specified in the Software Requirements Specification (SRS) and User Manual. No clinical data was required or provided. Results confirmed the device performs all intended actions without errors impacting safety or efficacy.

Technological Characteristics

Software-only PACS workstation. Operates on Windows-based platforms using Windows Presentation Foundation (WPF) and XBAP technology. Supports DICOM 3.0/3.1 standards for image connectivity and integration. Features include Multi Planar Reconstruction (MPR), cine display, and RIS integration. No patient-contacting components. Software level of concern is classified as Moderate.

Indications for Use

Indicated for trained professionals, physicians, nurses, and technicians to receive, communicate, process, manipulate, enhance, store, and display digital medical images from various imaging sources for clinical review. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• IMAGEGRID RADIOLOGY VIEWER SYSTEM (K092949)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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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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: [e-mail] Phone: [phone]

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.

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- 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

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#### 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".