IntelliSpace Radiology
Device Facts
| Record ID | K182926 |
|---|---|
| Device Name | IntelliSpace Radiology |
| Applicant | Philips Healthcare Informatics, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Dec 6, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Intended 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.
Device Story
IntelliSpace Radiology is a client-server software system for radiology image management. It receives, processes, displays, and distributes medical images (CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, OP) via DICOM. Operated by clinicians on general-purpose hardware, it provides tools for image navigation, measurement (linear, angle, Cobb, ROI), and annotation. It supports advanced mammography, tomosynthesis slice indicators, and slab views. The system integrates with hospital/radiology information systems and third-party applications like PowerScribe. Clinicians use the output for diagnostic review and clinical decision-making. The device facilitates efficient workflow, remote reading, and teleradiology, potentially improving diagnostic accuracy and patient care delivery.
Clinical Evidence
No clinical data required. Substantial equivalence supported by non-clinical verification and validation testing, including software life cycle processes (IEC 62304), risk management (ISO 14971), and usability engineering (IEC 62366-1).
Technological Characteristics
Software-based PACS; client-server architecture; Windows OS; TCP/IP networking; DICOM compliant. Supports high-resolution diagnostic monitors. Features include image processing, measurement tools, and Advanced Mammography module. Software level of concern: moderate. Sterilization: N/A (software).
Indications for Use
Indicated for use by trained professionals (radiologists, physicians, administrators, technicians) for the presentation, processing, measurement, and distribution of medical images and data in clinical environments. Includes an Advanced Mammography module. Contraindicated for primary interpretation of lossy compressed mammographic images or 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
- IntelliSpace PACS 4.x (K111804)
Related Devices
- K150707 — IntelePACS · Intelerad Medical Systems Incorporated · May 27, 2015
- K063267 — ISITE PACS, V 4. X · Stentor Inc., A Philips Medical Systems Co. · Nov 9, 2006
- K111804 — INTELLISPACE PACS 4.X · Philips Healthcare Informatics, Inc. · Jul 28, 2011
- K231360 — Ambra PACS · Dicom Grid Dba Ambra Health · Jun 7, 2023
- K173588 — Illumeo System · Philips Medical Systems Technologies , Ltd. · Jan 12, 2018
Submission Summary (Full Text)
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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
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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
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### 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Philips Healthcare Informatics, Inc.
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5 510(K) SUMMARY
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# 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.<br>4430 Rosewood Drive, Suite 200<br>Pleasanton, CA 94588<br>USA<br>Establishment Registration Number: 2954704 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elfriede Pagan<br>Sr. Manager, Regulatory Affairs<br>Phone: (321) 339-9144<br>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
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#### 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.
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#### 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<br>Radiology<br>(subject device) | Predicate<br>IntelliSpace<br>PACS 4.x<br>(K111804) |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software Image and Information management<br>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<br>modalities types | Yes -<br>CT, MR, NM, US,<br>XA, PET, CR, DX,<br>DR, RF, RT, MG,<br>SC, VL, and OP | Yes-<br>CT, MR, NM, US,<br>XA, PET, DX, DR,<br>RF, RT, MG, SC,<br>VL |
| 9. | Support for IHE Profiles for Key Image Notes (KIN)<br>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<br>Radiology<br>(subject device) | Predicate<br>IntelliSpace<br>PACS 4.x<br>(K111804) |
| 13. | Supported Data and Multi Modalities | Supports<br>receiving,<br>sending, printing,<br>storing and<br>displaying studies<br>received from the<br>following modality<br>types via DICOM:<br>CT, MR, NM, US,<br>XA, PET, CR, DX,<br>DR, RF, RT, MG,<br>SC, VL, and OP<br>as well as<br>hospital/<br>Radiology<br>information<br>systems. | Supports<br>receiving,<br>sending, printing,<br>storing and<br>displaying studies<br>received from the<br>following modality<br>types via DICOM:<br>CT, MR, NM, US,<br>XA, PET, DX, DR,<br>RF, RT, MG, SC,<br>VL as well as<br>hospital/<br>Radiology<br>information<br>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<br>Radiology<br>(subject device) | Predicate<br>IntelliSpace<br>PACS 4.x<br>(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<br>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
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