(58 days)
Not Found
No
The document describes a PACS system for managing and viewing radiotherapy data. There is no mention of AI or ML capabilities in the intended use, device description, or any other section. The focus is on data storage, retrieval, and visualization tools.
No
The device is described as software for reviewing and assessing DICOM based datasets in a radiotherapy environment for trained medical professionals. It is specifically stated as "intended for reviewing purposes only and is not capable to generate new or modified RT plan data." It is a tool for managing and visualizing data, not for direct treatment or therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data." While it assists in reviewing and assessment, it does not perform diagnosis itself. Additionally, it states, "INFINITT RT PACS, is not intended for diagnostic image review on mobile devices." The general purpose of a PACS system is image management and visualization, not typically direct diagnosis.
Yes
The device description explicitly states it is a "software medical device" and describes its functions solely in terms of software operations on DICOM data. There is no mention of accompanying hardware components that are part of the device itself.
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 INFINITT RT PACS is a software medical device used for reviewing and assessment of DICOM based datasets generated in a radiotherapy environment. It handles images and data related to treatment planning and dose distribution.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples from a patient. Its function is centered around managing and visualizing medical images and related data.
The device falls under the category of medical image management and review software, specifically for radiation therapy.
N/A
Intended Use / Indications for Use
INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links.
Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line.
Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices.
Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, MR, PET, RT-IMAGE (DRR/Portal/Simulator Image), RT-STRUCTURE, RT-PLAN, RT-DOSE
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).
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)
Nonclinical Testing: The Infinitt RT PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, and followed the process documented in the Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. Summary: Based on the performance as documented in the Validation Testing, Infinitt RT PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.
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/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font compared to the rest of the text.
INFINITT Healthcare Co., Ltd. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
February 13, 2020
Re: K193498
Trade/Device Name: INFINITT RT PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 31, 2019 Received: December 17, 2019
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193498
Device Name Infinitt RT PACS
Indications for Use (Describe)
INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.
| 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) |
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3
Image /page/3/Picture/0 description: The image contains the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, gray letters. The logo is simple and professional, and it is likely used to represent the company's brand.
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
Mr. Sang Wook Cho Chief Quality Officer, Research and Development Center INFINITT Healthcare Co. Ltd. 12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea Tel: +82-2-2194-1631 Fax: +82-2-6969-5455 Email: bigmouse@infinitt.com
Date Prepared: December 9, 2019
II. DEVICE
Name of Device: Infinitt RT PACS Common or Usual Name: Picture Archiving Communications System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ
III. PREDICATE DEVICES
Primary Predicate Device: ProKnow DS (K182855), by ProKnow LLC, CFR 892.2050, Product Code LLZ.
IV. DEVICE DESCRIPTION
Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links.
Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line.
Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices.
Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.
V. INDICATIONS FOR USE
INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE. RT-PLAN. RT-DOSE. RT-IMAGE. CR. CT. MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data.
4
Image /page/4/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo features a blue sphere on the left side, with the word "INFINITT" in large, bold, blue letters to the right of the sphere. Below the word "INFINITT" is the word "Healthcare" in a smaller font size.
INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The subject device and predicate are both PACS, which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use.
Any differences between the predicate and the subject device has no negative impact on the device safety or efficacy and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
| Functionality | Subject Device
INFINITT RT PACS | Predicate Device
ProKnow DS
(K182855) | If different, Impact on Safety and or
Efficacy |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardware
Requirements | OS: Windows 7 or higher
Processor: Intel Core i5
or higher
Memory: 4GM or more
Graphic card:
1920x1080, 32bpp | OS: Windows 7, 10,
and macOS High
Sierra
Processor: Dual
Core2.2+ GHz Intel or
equivalent processor
Memory: 8GB
Graphic card: WebGL
compatible graphic
card
1280x800 effective
display resolution
(1900x1080
recommended) | Yes, there are differences in the computer
requirements which are dependent upon
software development and implementation.
The differences do not raise any new
potential safety risks and therefore, we
believe there is no impact on safety or
efficacy for the subject device. |
| Enterprise
distribution of
images and data
via Internet or
Intranet | Yes | Yes | No differences |
| Networking
Communications
Protocol - DICOM
3.1 | Yes | No | Yes, there are differences. The subject
device uses the DICOM 3.1 FDA recognized
standard for network communications and
device interoperability. The differences do
not raise any new potential safety risks and
therefore, we believe there is no impact on
safety or efficacy for the subject device. |
| Functionality | Subject Device
INFINITT RT PACS | Predicate Device
ProKnow DS
(K182855) | If different, Impact on Safety and or
Efficacy |
| Image
Compression | No compression | No compression | No differences |
| Supported DICOM
Standard SOP
Classes | CT Image Storage
MR Image Storage
PET Image Storage
RT Dose Storage
RT Structure Set Storage
RT Plan Storage
RT Ion Plan Storage
RT Image Storage
Secondary Capture
Image Storage | CT Image Storage
MR Image Storage
RT Dose Storage
RT Structure Set
Storage
RT Plan Storage
RT Ion Plan Storage
Spatial Registration | Yes, there are differences in the supported
DICOM SOP Classes. The subject device
complies with the FDA recognized DICOM
Standard and has been tested. The product
functions are explained in labeling and does
not raise any new potential safety risks and
therefore, we believe there is no impact on
safety or efficacy for the subject device. |
| Worklist | Search Filter
Search Criteria
Examined Patient History
Patient List
Latest Plan List | Patient List
Filter Workspace
Filter Patient
Patient Collection | Yes, the difference is how the data is
retrieved. This does not raise any new
potential safety risks and therefore, we
believe there is no impact on safety or
efficacy for the subject device. |
| Image Display
Function | Slice Navigation
Window/Level
Zoom
Zoom to Selection
Pan
Reset | Slice Navigation
Window/Level
Zoom
Zoom to Selection
Zoom to Fit
Pan
Probe | There are differences where the subject
device does not have the exact features of
the predicate. The subject device has been
validated and features and functions are
documented in the device labeling. The
differences do not raise any new potential
safety risks and therefore, we believe there
is no impact on safety or efficacy for the subject device. |
| Annotation/Measu
rement | Yes | No | The subject device supports
annotation/measurement. The subject
device has been validated and features and
functions are documented in the device
labeling. The difference does not raise any
new potential safety risks and therefore, we
believe there is no impact on safety or
efficacy for the subject device. |
| Multi-Planar
Reformation | Axial, Sagittal, Coronal | Axial, Sagittal, Coronal | No differences |
| 3D Volume
Rendering | Yes | No | The subject device supports 3D Volume
Rendering, has been validated and features
and functions are documented in the device
labeling. The difference does not raise any
new potential safety risks and therefore, we
believe there is no impact on safety or
efficacy for the subject device. |
| Image Capture
Tool | Yes | No | The subject device supports an Image
Capture Too, has been validated, and
features and functions are documented in
the device labeling. The difference does not
raise any new potential safety risks and |
| Functionality | Subject Device
INFINITT RT PACS | Predicate Device
ProKnow DS
(K182855) | If different, Impact on Safety and or
Efficacy |
| Contouring Tool | No | Yes | therefore, we believe there is no impact on
safety or efficacy for the subject device.
The subject device does not support a
Contouring Tool. The subject device has
been validated and features and functions
are documented in the device labeling. The
difference does not raise any new potential
safety risks and therefore, we believe there
is no impact on safety or efficacy for the
subject device. |
| Display ROI | Yes | Yes | No differences |
| Plan Information | Yes | Yes | No differences |
| Beam Information | Yes | Yes | No differences |
| Display Dose
Distribution | Yes | Yes | No differences |
| Isodose Level
Setting | Yes | Yes | No differences |
| Dose Volume
Histograms | Yes | Yes | No differences |
| Scorecards | Yes | Yes | No differences |
| Plan Summation | Dose Composition based
on the image fusion | Dose Composition
based on the spatial
registration | The difference on how each device handles
Plan Summation. The subject device has
been validated and the difference does not
raise any new potential safety risks and
therefore, we believe there is no impact on
safety or efficacy for the subject device. |
| Plan Comparison | Yes | No | The subject device supports Plan
Comparison, has been validated and
features and functions are documented in
the device labeling. The difference does not
raise any new potential safety risks and
therefore, we believe there is no impact on
safety or efficacy for the subject device. |
| Display
DRR/Portal/Simul
ator Image | Yes | No | The subject device supports
DRR/Portal/Simulator Image, has been
validated and features and functions are
documented in the device labeling. The
difference does not raise any new potential
safety risks and therefore, we believe there
is no impact on safety or efficacy for the
subject device. |
| HIS Interface | Yes | No | The subject device supports HIS Interface.
The subject device has been validated and
features and functions are documented in
the device labeling. The difference does not
raise any new potential safety risks and
therefore, we believe there is no impact on
safety or efficacy for the subject device. |
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Image /page/5/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular emblem on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller, lighter font.
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Image /page/6/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, lighter-colored letters.
7
Image /page/7/Picture/0 description: The image shows the logo for Infinit Healthcare. The logo consists of a blue sphere on the left, with the word "INFINITT" in large, bold, blue letters to the right of the sphere. Below the word "INFINITT" is the word "Healthcare" in smaller, lighter blue letters.
VII. PERFORMANCE DATA
Nonclinical Testing:
The Infinitt RT PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Summary:
Based on the performance as documented in the Validation Testing, Infinitt RT PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.
The following Standards were used to develop Infinitt RT PACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements:
- ISO14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices Applications . of risk management to medical devices, FDA FR Recognition # 5-40.
- NEMA PS 3.1 3.20 (2016, Digital Imaging and Communications in Medicine ● (DICOM) Set, FDA FR Recognition # 12-300.
- IEC 62304:2006, Medical device software Software life cycle processes, FDA FR ● Recognition # 13-32.
- FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
VIII. CONCLUSIONS
The 510(k) Pre-Market Notification for Infinitt RT PACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.