(84 days)
Not Found
No
The document describes a standard PACS system for image management and display, with no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No
The device is described as medical image and information management software for viewing, processing, and managing digital medical images, not for providing therapy or treatment.
Yes
The device description states that McKesson Radiology "includes the primary diagnostic viewer McKesson Radiology Station," indicating its role in diagnosis.
Yes
The device description explicitly states that McKesson Radiology consists of "configurable software-only applications." While it requires off-the-shelf hardware for installation and use, the device itself is described as solely software.
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 McKesson Radiology is a medical image and information management software. Its primary functions involve receiving, transmitting, storing, archiving, retrieving, managing, displaying, printing, and processing digital medical images from various imaging modalities (X-Ray, CT, MRI, Ultrasound, Nuclear Medicine).
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples from the human body.
The device is a Picture Archiving and Communication System (PACS) used for managing and displaying medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
McKesson Radiology™ is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.
McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossless compressed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine, as well as medical images obtained from other DICOM-compliant modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using cleared monitors intended for mammography display.
McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
Product codes
LLZ
Device Description
McKesson Radiology, a Picture Archiving and Communication System (PACS), consists of configurable software-only applications that receive, transmit. store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. It includes the primary diagnostic viewer McKesson Radiology Station, clinical-reference viewers, workflow tools and administrative tools. Although the primary McKesson Radiology functionalities, such as DICOM study acquisition, storage, and archival, are intended to be installed and used within a hospital or health care facility environment, the viewing, reporting and administrative functions are intended for use both inside and outside of these settings by qualified healthcare practitioners.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine, as well as medical images obtained from other DICOM-compliant modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
Although the primary McKesson Radiology functionalities, such as DICOM study acquisition, storage, and archival, are intended to be installed and used within a hospital or health care facility environment, the viewing, reporting and administrative functions are intended for use both inside and outside of these settings by qualified healthcare practitioners.
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)
Verification and validation testing was performed on McKesson Radiology to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2003, IEC 62304:2006 and ISO 14971:2007/ EN 14971:2012. In all instances, McKesson Radiology functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.
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).
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JUL 02 2014
MCKESSO!
Empowering Healthcare
510(k) SUMMARY McKesson Medical Imaging Company's McKesson Radiology Device
McKesson Medical Imaging Company 130 - 10711 Cambie Road Richmond, B.C. Canada, V6X 3G5
510(k) Owner and Contact:
Gilbert Wong Vice President, Regulatory Operations McKesson Medical Imaging Company 130 - 10711 Cambie Road Richmond. BC Canada V6X 3G5
Phone: 604-821-6338 Fax: 604-279-5468 E-mail: Gilbert.Wong@McKesson.com
Date Prepared:
March 31, 2014
Proprietary Name: Common/Usual Name: Classification Name: Classification Regulation: Classification Product Code: Device Class: Classification Panel: Predicate Devices:
McKesson Radiology™M PACS Picture Archiving Communications System 21 CFR 892.2050 LLZ Class II Radiology Devices Horizon Medical Imaging (K043146) Fuji Synapse Workstation Software (K051553)
Intended Use / Indications for Use
McKesson Radiology™ is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.
McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and
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NEKESSON
Empowering Healthcare
non-lossless compressed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine, as well as medical images obtained from other DICOM-compliant modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using cleared monitors intended for mammography display.
McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
Technological Characteristics
McKesson Radiology, a Picture Archiving and Communication System (PACS), consists of configurable software-only applications that receive, transmit. store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. It includes the primary diagnostic viewer McKesson Radiology Station, clinical-reference viewers, workflow tools and administrative tools. Although the primary McKesson Radiology functionalities, such as DICOM study acquisition, storage, and archival, are intended to be installed and used within a hospital or health care facility environment, the viewing, reporting and administrative functions are intended for use both inside and outside of these settings by qualified healthcare practitioners.
Performance Data
Verification and validation testing was performed on McKesson Radiology to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2003, IEC 62304:2006 and ISO 14971:2007/ EN 14971:2012. In all instances, McKesson Radiology functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.
Substantial Equivalence
McKesson Radiology is substantially equivalent to the identified predicate devices which include the cleared Horizon Medical Imaging device (K043146) and the Fuji Synapse Workstation Software (K051553), as well as other similar, if not identical, legally commercially available devices in U.S. Interstate commerce. Specifically, McKesson Radiology has the same general intended use and similar indications for use,
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K140969
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MEKESSON
Empowering Healthcare
technological characteristics and principles of operation compared to these previously cleared predicate devices.
The minor technological differences between McKesson Radiology and its predicate devices raise no new issues of safety or effectiveness. Thus, McKesson Radiology is substantially equivalent to previously-cleared predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
McKesson Medical Imaging Company % Mr. Paul Sumner Director, Regulatory Affairs McKesson Technologies, Inc. 5995 Windward Parkway ALPHARETTA GA 30005
Re: K140909
Trade/Device Name: McKesson Radiology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 24, 2014 Received: June 27, 2014
Dear Mr. Sumner:
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.
4
Page 2-Mr. Sumner
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/ResourcesforYou/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. O'Hara for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140909
Device Name McKesson Radiology™
Indications for Use (Describe)
McKesson Radiology™ is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, digital medical images, digital medical video and associated patient and medical information. McKesson Radiology includes a suite of standalone, web-enabled software components. and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.
McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography. Magnetic Resonance Imaging, Ultrasound, and Nuclear Medical images obtained from other DICOM-compliant modalitics.
Lossy compressed manmographic images and digitized film serven images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using cleared monitors intended for mammography display.
McKesson Radiology is indicated for use by qualified healtheare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Michael D. O'Hara |
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