(30 days)
No
The summary mentions image processing and analysis but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard PACS functionalities.
No
The device is a Picture Archiving and Communication System (PACS) intended for archiving, retrieving, processing, and displaying medical images and data. It does not perform any direct therapeutic action on a patient.
Yes
Explanation: The device is intended to provide complete and scalable PACS solutions for hospital and related institutions/sites, which will archive, retrieve, process and display medical images and data. It also contains clinical applications that assist the processing, analyzing, and comparing of medical images. This functionality aids in diagnosis by enabling medical professionals to review and interpret various medical images.
Yes
The device description explicitly states "Image Management V15 is a software based system". While it interacts with hardware (modalities, displays), the device itself, as described, is the software component.
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 this device is a PACS (Picture Archiving and Communication System) intended for archiving, retrieving, processing, and displaying medical images and data from various imaging modalities (CT, MR, X-Ray, etc.). It also includes tools for reviewing, dictating, and reporting on these images.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is centered around managing and displaying medical images.
Therefore, the device described is a medical imaging management system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical images from different. modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML.
*For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.
Product codes
LLZ
Device Description
Image Management V15 is a software based system and is intended to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display images and data from all hospital modalities and information systems. The device is to be used by trained professionals including, but not limited to, physicians and medical technicians. The device contains clinical applications that assist the processing, analyzing and comparing medical images. It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
IM V15 supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM (Digital Imaging and Communications in Medicine): Computed Tomography (CT), Magnetic Resonance (MR), Nuclear Medicine (NM), Ultrasound (US), X-Ray (XR), X-Ray Angiography (XA), Positron Emission Tomography (PET), Computed Radiography (CR), Digital Radiography (Abbreviation not defined by the DICOM standard) (DR) Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP) as well as hospital/radiology information systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DR, CT, MR, NM, ECG, US, MG, DBT, OP, OPT, Computed Tomography (CT), Magnetic Resonance (MR), Nuclear Medicine (NM), Ultrasound (US), X-Ray (XR), X-Ray Angiography (XA), Positron Emission Tomography (PET), Computed Radiography (CR), Digital Radiography (DR), Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and related institutions/sites, radiologists and physicians, clinicians, trained professionals including, but not limited to, physicians and medical 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)
Performance tests have been performed on Image Management v15.
Image Management v15 has been tested in accordance with Philips verification and validation processes. Verification and validation tests have been performed to address intended characteristics, technological use. specifications and risk management results.
The test results in this 510(k) premarket notification demonstrate that Image Management v15 complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and is substantially equivalent to the primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARESTREAM PACS (K110919)
Reference Device(s)
Carestream Vue PACS (K122523), Carestream Vue PACS (K170580), Carestream Vue Motion (K151774)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems Technologies Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
April 24, 2024
Re: K240822
Trade/Device Name: Image Management V15 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 25, 2024 Received: March 25, 2024
Dear Prithul Bom:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Image Management V15
Indications for Use (Describe)
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical images from different. modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML.
*For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
The Company's 510(k) Summary is provided below on the following page.
4
510(k) SUMMARY Philips Medical Systems Image Management Application
| K240822 | |
|---|---|
| Company's Name and Address | Philips Medical Systems Technologies Ltd. |
| 2 Hapnina Street, P.O. Box 46 | |
| Raanana Central, Israel 4321538 Phone: +9 7297625555 | |
| Contact Person | Shlomit Brandis Kepler |
| Sr. Regulatory Affairs Specialist | |
| shlomit.brandiskepler@philips.com | |
| +972547790828 | |
| Date | April 23, 2024 |
| Device Tradename | Image Management V15 |
| Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Classification | 21 CFR 892.2050 |
| Predicate Device | CARESTREAM PACS (K110919) |
| Reference Devices | Carestream Vue PACS (K122523) |
| Carestream Vue PACS (K170580) | |
| Carestream Vue Motion (K151774) | |
| Device Description and | |
| Technological | |
| Characteristics | Image Management V15 is a software based system and is |
| intended to provide completely scalable local and wide area | |
| PACS (Picture Archiving and Communication System) | |
| solutions for hospital and related institutions/sites, which | |
| will archive, distribute, retrieve, process and display images | |
| and data from all hospital modalities and information | |
| systems. The device is to be used by trained professionals | |
| including, but not limited to, physicians and medical | |
| technicians. The device contains clinical applications that | |
| assist the processing, analyzing and comparing medical | |
| images. It is a single device that integrates review, dictation | |
| and reporting tools to create a productive work environment | |
| for the radiologists and physicians. |
IM V15 supports receiving, sending, printing, storing and
displaying studies received from the following modality
types via DICOM (Digital Imaging and Communications
in Medicine): Computed Tomography (CT), Magnetic
Resonance (MR), Nuclear Medicine (NM), Ultrasound
(US), X-Ray (XR), X-Ray Angiography (XA), Positron
Emission Tomography (PET), Computed Radiography
(CR), Digital Radiography (DX), Digital Radiography
(Abbreviation not defined by the DICOM standard) (DR) |
| | Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP) as well as hospital/radiology information systems. |
| Indications for Use | Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. |
| | The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. |
| | The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical data and medical images from different modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. |
| | The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard Html. |
| | *For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. |
| Substantial Equivalence | Image Management v15 is as safe and effective as its predicate device. Both devices have similar indications for use, technological characteristics, and principles of operation. The minor technological differences between the Image Management and its predicate device raise no new issues of safety or effectiveness. |
| | The table below summarizes the substantive feature/technological similarities and differences between the subject and predicate devices. |
| | |
5
PHILIPS
6
| Comparison Feature | Subject Device | Primary Predicate Device | |
|---|---|---|---|
| Philips' | Carestream PACS | ||
| Image Management v15 | (K110919) | ||
| Device Class | Class II | Class II | |
| Classification Panel | Radiology | Radiology | |
| Product Code | LLZ | LLZ | |
| Regulation | |||
| Description | System, Image Processing, | ||
| Radiological | System, Image Processing, | ||
| Radiological | |||
| Regulation Number | 892.2050 | 892.2050 | |
| Indications for Use | Image Management is intended | ||
| to provide complete and scalable | |||
| local and wide area PACS | |||
| solutions for hospital and related | |||
| institutions/sites, which will | |||
| archive, distribute, retrieve, | |||
| process and display medical | |||
| images and data from hospital | |||
| medical imaging and | |||
| information systems. | |||
| The device contains clinical | |||
| applications that assist the | |||
| processing, analyzing and | |||
| comparing of medical images. It | |||
| is a single device that integrates | |||
| the review, dictation and | |||
| reporting tools to create a | |||
| productive work environment | |||
| for the radiologists and | |||
| physicians. | |||
| The Image Management viewers | |||
| are used for patient exam | |||
| management by clinicians in | |||
| order to access and display | |||
| patient data, medical reports, | |||
| medical data and medical | |||
| images from different modalities | |||
| including but not limited to CR, | |||
| DR, CT, MR, NM, ECG, US, | |||
| MG*, DBT*, OP and OPT. | |||
| The device provides wireless | |||
| and portable access to medical | |||
| images for remote reading or | |||
| referral purposes from web | The CARESTREAM PACS is an | ||
| image management system whose | |||
| intended use is to provide | |||
| completely scaleable local and | |||
| wide area PACS solutions for | |||
| hospital and related | |||
| institutions/sites, which will | |||
| archive, distribute, retrieve and | |||
| display images and data from all | |||
| hospital modalities and | |||
| information systems. | |||
| The system contains interactive | |||
| tools in order to ease the process | |||
| of analyzing and comparing three | |||
| dimensional (3D) images. It is a | |||
| single system that integrates the | |||
| review, dictation and reporting | |||
| tools that creates a productive | |||
| work environment for the | |||
| radiologists and physicians. | |||
| The CARESTREAM PACS | |||
| Lightweight Viewer software | |||
| program is used for patient | |||
| management by the referral | |||
| community in order to access and | |||
| display patient data, medical | |||
| reports, and medical images from | |||
| different modalities including CR, | |||
| DR, CT, MR, NM and US after | |||
| the primary reading has been | |||
| completed on dedicated diagnostic | |||
| workstations. | |||
| Comparison Feature | Subject Device | ||
| Philips' | |||
| Image Management v15 | Primary Predicate Device | ||
| Carestream PACS | |||
| (K110919) | |||
| browsers using current standard | |||
| Html. | |||
| *For primary interpretation and | |||
| review of mammography | |||
| images, only use display | |||
| hardware that is specifically | |||
| designed for and cleared by | |||
| FDA for mammography. | The CARESTREAM PACS | ||
| Lightweight Viewer provides | |||
| wireless and portable access to | |||
| medical images for referral | |||
| purposes. It is not intended to be | |||
| used as, or to replace, a full | |||
| diagnostic workstation or system | |||
| and should be used only when | |||
| there is no access to a workstation. | |||
| This device is not to be used for | |||
| mammography. | |||
| Available Clinical Tools | |||
| Cardiac CT | |||
| Application | Yes | Yes | |
| ECG Application | Yes | No | |
| Cardiology | |||
| (Echocardiography, | |||
| XA) | Yes | Yes | |
| Coronary Artery | |||
| Analysis application | Yes | Yes | |
| Vessel analysis | |||
| application | Yes | Yes | |
| Digital Subtraction | |||
| Application | Yes | No | |
| Calcium Scoring | |||
| application | Yes | Yes | |
| 3D analysis | |||
| application | Yes | Yes | |
| Volume Matching | |||
| Application | Yes | Yes | |
| Hybrid NM viewer | |||
| application | Yes | Yes | |
| Mammography image | |||
| display Application | Yes | Yes | |
| PowerViewer | |||
| application | Yes | Yes | |
| MPR application | Yes | Yes | |
| CT Perfusion | |||
| application | Yes | No | |
| MR Perfusion | |||
| application | Yes | No | |
| MR Diffusion | |||
| application | Yes | No | |
| Comparison Feature | Subject Device | ||
| Philips' | |||
| Image Management v15 | Primary Predicate Device | ||
| Carestream PACS | |||
| (K110919) | |||
| Lesion Management | |||
| Application | Yes | No | |
| Technological Characteristics | |||
| Supports DICOM | |||
| studies received from | |||
| different modality | |||
| types | Yes- CT, MR, NM, US, XR, | ||
| XA, PET, CR, DX, DR, RF, RT, | |||
| MG, SC, VL, OPT, ECG and | |||
| OP | Yes- CR, DR, CT, MR, NM, US, | ||
| XR, XA, MG, PET, DX, RF, RT, | |||
| MG, SC and VL | |||
| Web Diagnostic | |||
| Viewer | Yes | No | |
| OP & OPT modality | |||
| support | Yes |
Table 1: Substantial Equivalence
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are gray, and there is a thin black line underneath the word. The background is white, providing a clear contrast that makes the text easily readable.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are gray, and the background is white. A thin, dark line is located underneath the word.
In addition, the software naming convention is being introduced with a new branding, and will be titled Image Management, versus the previous use of Vue PACS.
Nonclinical Tests Performed
Performance tests have been performed on Image Management v15
Image Management v15 demonstrates compliance with the following International and FDA recognized consensus standards:
- ISO 14971 Medical devices Application of risk 0 management to medical devices
- 0 IEC 62304 Medical device software - Software life cycle processes
- NEMA PS 3.1-3.22 - - Digital Imaging 0 and Communications in Medicine (DICOM) Standard
Image Management V15 has been tested in accordance with Philips verification and validation processes. Verification and validation tests have been performed to address intended characteristics, technological use. specifications and risk management results.
The test results in this 510(k) premarket notification demonstrate that Image Management v15 complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and is substantially equivalent to the primary predicate device.
9
Conclusion:
Based on the technological characteristics of the devices, Philips Medical Systems Technologies Ltd. believes that Image Management V15 and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.