(45 days)
Not Found
No
The document describes standard image processing and display software for various modalities, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The software is for processing, viewing, and distributing medical images, not for providing therapy or treatment.
Yes
The software is used by trained professionals, including radiologists and physicians, for the "presentation, processing, measurement and distribution of images and associated data throughout a clinical environment." This directly supports professional interpretation and decision-making for patient care, which is characteristic of a diagnostic device. While it doesn't make an automated diagnosis, it provides crucial tools for human diagnosticians.
Yes
The device is described as a "software package" and a "modification of the previously cleared IntelliSpace PACS 4.x software device". While it is used with "general purpose computing hardware", the description focuses solely on the software's functionality and does not mention any specific hardware components being part of the device itself.
Based on the provided information, 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 the IntelliSpace Radiology Software is used for the "presentation, processing, measurement and distribution of images and associated data throughout a clinical environment." It handles images from various imaging modalities (CT, MR, etc.).
- 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 medical imaging data.
Therefore, the IntelliSpace Radiology Software falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Mammography images may only be interpreted using display monitors approved for digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing. measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians.
a clinical environment.
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)
The subject of this premarket submission, IntelliSpace Radiology did not require clinical studies to support equivalence. Non-clinical performance testing was performed on IntelliSpace Radiology product and demonstrates compliance with ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1- PS 3.20 DICOM, and Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Software verification and validation testing were conducted. The software was considered a "moderate" level of concern. Verification and Validation tests were performed to address intended use, technological characteristics claims, requirement specifications and risk management results. The test results demonstrated compliance with the standards and adequacy for intended use. Risk management activities showed all risks were sufficiently mitigated, no new risks introduced, and overall residual risks acceptable.
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/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Healthcare Informatics, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street. Nw BUFFALO, MN 55313
December 6, 2018
Re: K182926
Trade/Device Name: IntelliSpace Radiology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 27, 2018 Received: November 28, 2018
Dear Mark Job:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Robert A. 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) K182926
Device Name IntelliSpace Radiology
Indications for Use (Describe)
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Mammography images may only be interpreted using display monitors approved for digital 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
Philips Healthcare Informatics, Inc.
Image /page/3/Picture/2 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. A thin black line is visible at the bottom of the image.
5 510(K) SUMMARY
4
Image /page/4/Picture/1 description: The image contains the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface. The background is white, providing a strong contrast to the blue letters.
510(k) Summary
IntelliSpace Radiology
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.
Date Prepared: September 5, 2018
I. Submitter's name and address
| Manufacturer: | Philips Healthcare Informatics, Inc.
4430 Rosewood Drive, Suite 200
Pleasanton, CA 94588
USA
Establishment Registration Number: 2954704 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elfriede Pagan
Sr. Manager, Regulatory Affairs
Phone: (321) 339-9144
E-mail: phiiregulatory@philips.com |
II. Device information
Subject Device:
IntelliSpace Radiology Device Name: Common/Usual Name: Radiology Image and Information Management System Classification: Classification name: Picture Archiving and Communications System Device class: Class II Classification regulation: 21 CFR 892.2050 Classification panel: Radiology Product Code: LLZ
5
Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. A thin black line is present underneath the word, spanning its entire length.
III. Predicate device information
Predicate Device:
| Trade name: | IntelliSpace PACS 4.x |
|---|---|
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| 510(k) clearance: | K111804 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |
IV. Device Description
The subject device IntelliSpace Radiology product described in this section is a modification of the previously cleared IntelliSpace PACS 4.x software device (K111804). Changes made or being implemented are described in Section 12 'Substantial Equivalence Discussion'.
IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing. measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
V. Indications for Use
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Mammography images may only be interpreted using display monitors approved for digital mammography.
6
Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is white, providing a strong contrast that makes the word stand out.
Comparison of Technological Characteristics with the Predicate Device VI.
The subject device IntelliSpace Radiology (ISR) product described in this section is a modification of the previously cleared IntelliSpace PACS 4.x software device (K111804). The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment by healthcare professionals.
IntelliSpace Radiology product uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, and standard measurement tools. Both the subject device and the predicate device provide Diagnostic Review Solution for radiology and other areas where images are utilized, such as Visible Light. ISR is utilizing client-server technology, communication and interoperability with hospital systems, such as radiology workflow providers and image archives.
A comparison matrix below (please see Table 5-1 below) provides a comparison which outlines a high-level overview of the differences and similarities between IntelliSpace Radiology and the predicate device, IntelliSpace PACS 4.x (K111804).
| # | Specification / Feature | IntelliSpace
Radiology
(subject device) | Predicate
IntelliSpace
PACS 4.x
(K111804) |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software Image and Information management
system | Yes | Yes |
| 2. | Hardware Platform requirements | Yes | Yes |
| System Configuration | | | |
| 3. | Windows Operating System | Yes | Yes |
| 4. | TCP-IP Network Protocol | Yes | Yes |
| 5. | Supports High Resolution Diagnostic Monitors | Yes | Yes |
| 6. | Storage capabilities | Not supported | Yes |
| 7. | Multiple monitor support | Yes | Yes |
| Communication and Interoperability with other image management systems | | | |
| 8. | Supports DICOM studies received from different
modalities types | Yes -
CT, MR, NM, US,
XA, PET, CR, DX,
DR, RF, RT, MG,
SC, VL, and OP | Yes-
CT, MR, NM, US,
XA, PET, DX, DR,
RF, RT, MG, SC,
VL |
| 9. | Support for IHE Profiles for Key Image Notes (KIN)
and Digital Breast Tomosynthesis (DBT) | Yes | No |
| Operating Platform requirements | | | |
| 10. | Client-server technology | Yes | Yes |
| 11. | Thin client installer | Yes | Yes |
| 12. | Multiple concurrent user support | Yes | Yes |
| Interfaces with other Image management systems | | | |
| # | Specification / Feature | IntelliSpace
Radiology
(subject device) | Predicate
IntelliSpace
PACS 4.x
(K111804) |
| 13. | Supported Data and Multi Modalities | Supports
receiving,
sending, printing,
storing and
displaying studies
received from the
following modality
types via DICOM:
CT, MR, NM, US,
XA, PET, CR, DX,
DR, RF, RT, MG,
SC, VL, and OP
as well as
hospital/
Radiology
information
systems. | Supports
receiving,
sending, printing,
storing and
displaying studies
received from the
following modality
types via DICOM:
CT, MR, NM, US,
XA, PET, DX, DR,
RF, RT, MG, SC,
VL as well as
hospital/
Radiology
information
systems. |
| 14. | Federation | Yes | Yes |
| 15. | Vendor Neutral Archive for Client | Yes | Yes |
| | Patient-Exam Worklist Browser | | |
| 16. | Patient Exam Query Tool | Yes | Yes |
| 17. | Patient Exam Worklist Filters | Yes | Yes |
| | Image Display/Formatting/Navigation | | |
| 18. | Multiple Monitor layout option | Yes | Yes |
| 19. | Scales image to window | Yes | Yes |
| 20. | Next/Previous Image/ Series/ Page Options | Yes | Yes |
| 21. | Cine Toolset | Yes | Yes |
| 22. | Image/Series Linking | Yes | Yes |
| 23. | Image Rotate/Flip | Yes | Yes |
| 24. | Image Zoom/Pan | Yes | Yes |
| 25. | Scout lines Tool | Yes | Yes |
| 26. | Image Stacking | Yes | Yes |
| 27. | Hanging Protocols | Yes | Yes |
| 28. | Grayscale Softcopy Presentation State (GSPS) | Yes | Yes |
| 29. | Tomosynthesis Slice Indicator | Yes | No |
| 30. | Bidirectional Tomo Localizer | Yes | No |
| 31. | Tomo Slab View | Yes | No |
| 32. | Tomo Localizer Mode | Yes | No |
| | Measurement and Annotations | | |
| 33. | Measurement Tools | Yes | Yes |
| 34. | Linear Measurements (Ruler) | Yes | Yes |
| 35. | Angle | Yes | Yes |
| 36. | Cobb Measurement | Yes | Yes |
| 37. | ROI Circle | Yes | Yes |
| 38. | ROI Freehand | Yes | Yes |
| # | Specification / Feature | IntelliSpace
Radiology
(subject device) | Predicate
IntelliSpace
PACS 4.x
(K111804) |
| 40. | Point Value | Yes | Yes |
| 41. | Calibrating Images | Yes | Yes |
| 42. | Angle Line Ratio | Yes | No |
| 43. | Ultrasound Measurements | Yes | Yes |
| 44. | Annotation Tools | Yes | Yes |
| | Results | | |
| 45. | View/Print Diagnostic Reports from RIS | Yes | Yes |
| | Printing/Export/Save Images... | | |
| 46. | Printing images to Paper | Yes | Yes |
| 47. | Printing images to Film | Yes | Yes |
| 48. | Save images as BMP, JPEG, TIF files | Yes | Yes |
| 49. | Export of Patient-Exams | Yes | Yes |
| | General Usage | | |
| 50. | Designed for diagnostic review of images inside
and outside of Radiology | Yes | Yes |
| | Clinical Tools | | |
| 51. | Remote Reading Tools / Teleradiology | Yes | Yes |
| 52. | Image Filters | Yes | Yes |
| 53. | Variable Slice Thickness for CT (Slab Reading) | Yes | Yes |
| 54. | Exam Notes | Yes | Yes |
| 55. | Key Image Series | Yes | Yes |
| 56. | Patient Merging | Yes | Yes |
| 57. | Standard Mammography | Yes | Yes |
| 58. | Advanced Mammography Module | Yes | No |
| | Management Tools | | |
| 59. | Patient Management | Yes | Yes |
| 60. | Exam Management | Yes | Yes |
| 61. | Exception Study | Yes | Yes |
| 62. | User Security Access Management | Yes | Yes |
| 63. | Dictionary Management | Yes | Yes |
| 64. | Auditing Tools | Yes | Yes |
| 65. | Billing | Yes | Yes |
| 66. | Easy Client Installer | Yes | Yes |
| 67. | Data Migration | Yes | Yes |
| 68. | Workflow Layer | Yes | Yes |
| 69. | System Monitoring | Yes | Yes |
| | Third Party Application Support | | |
| 70. | PowerScribe | Yes | Yes |
| 71. | Cardiology Enterprise Viewer | Yes | Yes |
| 72. | Application Programming Interface | Yes | Yes |
| 73. | Universal Data Manager | Yes | No |
| 74. | IntelliSpace PACS Anywhere | Yes | No |
Table 5-1 Technological characteristics comparison
7
Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
8
Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
9
Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
The subject device, IntelliSpace Radiology, has implemented features designated to bring the product up to date with current technologies and customer requests. Presented technological differences are considered low risk, providing further support to clinicians in visualization. These functionalities were verified and validated, and do not raise new questions on safety and/or effectiveness. These features have not changed the intended use and operational principles of the device. Therefore, IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of technological characteristics.
VII. Performance Data
Section 16 'Software' provides a summary of the technical documentation, which includes nonclinical verification and validation tests. These tests are performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results, and according to the following International and FDA-recognized consensus standards and FDA guidance document.
The following performance data was provided in support of the substantial equivalence determination.
Summary of Non-clinical testing
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on IntelliSpace Radiology product and demonstrates compliance with the following International and FDArecognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices – Application of risk management to medical devices
- . IEC 62304 Medical device software - Software life cycle processes
- I IEC 62366-1 Medical devices – Part 1: Application of usability engineering to medical devices
- 트 NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- I Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could resultlead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to a minor injury to the patient or operator.
IntelliSpace Radiology was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, technological characteristics claims, requirement specifications and the risk management results.
The test results in this 510(k) premarket notification demonstrate that IntelliSpace Radiology:
- . complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- meets the acceptance criteria and is adequate for its intended use.
10
Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.
Therefore, IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of safety and effectiveness.
Summary of Clinical Testing
The subject of this premarket submission, IntelliSpace Radiology did not require clinical studies to support equivalence.
VIII. Substantial Equivalence Conclusion
IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of indications for use, design features, fundamental scientific technology, and safety and/or effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance testing. Verification and Validation (V&V) activities were performed for proposed IntelliSpace Radiology system and demonstrated that the predetermined acceptance criteria were successfully met. The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the subject device IntelliSpace Radiology is as safe and effective as its predicate device IntelliSpace PACS 4.x (K111804) without raising any new safety and/or effectiveness concerns.