(227 days)
Unfortunately, the provided text does not contain any K/DEN numbers for Reference Devices. The section "Reference Device(s)" explicitly states "Not Found".
No
The summary describes a PACS viewer with standard image manipulation tools (windowing, zoom, pan, measurement). There is no mention of AI/ML terms or functionalities that would typically involve such technologies (e.g., automated detection, segmentation, risk prediction).
No.
The device is described as a diagnostic, review, and analysis tool for medical images, not a device that treats or prevents disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for use as a diagnostic, review and analysis tool by trained professionals." Also, the "Summary of Performance Studies" mentions "diagnostic viewing capabilities."
Yes
The device description explicitly states "The MobileCT Viewer is a software-based Picture Archiving and Communication System (PACS)". While it interacts with hardware (servers and mobile devices), the device being cleared is the software itself, which performs the core functions of retrieving, displaying, and manipulating medical images.
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 MobileCT Viewer software program is designed to display and manipulate medical images (CT, MRI, X-ray) that are already acquired from the patient. It does not perform any tests on biological samples.
- Intended Use: The intended use is for diagnostic review and analysis of existing medical images by trained professionals.
The device is a medical image viewer and analysis tool, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals.
MobileCT Viewer provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Product codes
LLZ
Device Description
The MobileCT Viewer is a software-based Picture Archiving and Communication System (PACS) used with computing servers and specific mobile devices. DICOM-compliant medical images from CT : MRI, X-ray modalities are stored on the server component. MobileCT Viewer retrieves patent image data securely via a network connection with the server. DICOM files are losslessly compressed for network transfer and downloaded by MobileCT Viewer for display on the mobile device component. Communication and display on the mobile device assist trained professionals in the diagnostic interpretation, review and analysis of the medical images.
MobileCT Viewer includes the capability to perform to the displayed image:
- · adjust window width and level (i.e. contrast) values,
- · apply view transforms (e.g. zoom, pan, and rotation),
- · measure distances, and
- · display measurement lines and annotations.
MobileCT Viewer operates on off-the-shelf portable hardware devices and is therefore subject to factors not typical for reading room workstations (c.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
MobileCT Viewer provides wireless and portable access to medical innages. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
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
Description of the test set, sample size, data source, and annotation protocol: Nephosity, Inc. has performed multiple studies with qualified medical professionals. These medical professional tested MobileCT Viewer by evaluating the image quality of the medical inages of the supported modalities (i.e. CT, MRJ, X-ray ) under different environmental conditions. Results of these studies affirm the diagnostic viewing capabilities of MobileCT Viewer when used as indicated.
Additionally, Nephosity, Inc. has conducted performance and functional testing on the MobileCT Viewer software. In all cases, the software passed its performance requirements and met specifications. A summary of the results of the testion 9.6 and section 9.7) of Part XVI.
No animal or clinical testing was performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nephosity, Inc. has performed multiple studies with qualified medical professionals. These medical professional tested MobileCT Viewer by evaluating the image quality of the medical inages of the supported modalities (i.e. CT, MRJ, X-ray ) under different environmental conditions. Results of these studies affirm the diagnostic viewing capabilities of MobileCT Viewer when used as indicated.
Additionally, Nephosity, Inc. has conducted performance and functional testing on the MobileCT Viewer software. In all cases, the software passed its performance requirements and met specifications. A summary of the results of the testion 9.6 and section 9.7) of Part XVI.
No animal or clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K123082
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Part V. 510(k) Summary of Safety and Effectiveness
(the following information is in conformance with 21 CFR 807.92)
MAY 1 6 2013
19
Submitter
Nephosity, Inc. 615 Grant Avenue 3F San Francisco, CA 94108
Contact Person: Michael Pan, CEO 615 Grant Avenue 3F San Francisco, CA 94108 mjpan@nephosity.com +1 650 429 8917
Date Summary Prepared: April 24, 2013
Device name
Trade Name: MobileCT Viewer
Common Name: Medical Imaging Software T
Classification Name: System, Image Processing, Radiological (21 CFR. Part 892.2050, Product Code: LLZ)
Predicate device
K 103785 MobileMIM MIM Software Inc.
1
Indications for Use
The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals.
MobileCT Viewer provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Device description
The MobileCT Viewer is a software-based Picture Archiving and Communication System (PACS) used with computing servers and specific mobile devices. DICOM-compliant medical images from CT : MRI, X-ray modalities are stored on the server component. MobileCT Viewer retrieves patent image data securely via a network connection with the server. DICOM files are losslessly compressed for network transfer and downloaded by MobileCT Viewer for display on the mobile device component. Communication and display on the mobile device assist trained professionals in the diagnostic interpretation, review and analysis of the medical images.
MobileCT Viewer includes the capability to perform to the displayed image:
- · adjust window width and level (i.e. contrast) values,
- · apply view transforms (e.g. zoom, pan, and rotation),
- · measure distances, and
- · display measurement lines and annotations.
MobileCT Viewer operates on off-the-shelf portable hardware devices and is therefore subject to factors not typical for reading room workstations (c.g. screen size, environmental variability,
2
network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
MobileCT Viewer provides wireless and portable access to medical innages. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
Substantial equivalence
Table 1 provides evidence to facilitate the substantial equivalence determination between MobileCT Viewer and our chosen predicate. Mobile MIM (K103785).
There is a direct correlation between the Indication Statement / Intended Use of Mobile T Viewer with Mobile MIM. Both devices are software applications used by medical professionals in the diagnosis of patients by means of medical images.
MobileCT Viewer and MobileMM run on the same software platform- Apple iOS, and hardware platform- the Apple iPad (4th generation, late 2012) . MobileCT Viewer's technological characteristics are more limited than that of MobileMM, as MobileCT Viewer provides only viewing and simple image manipulation (which do not alter the image data. such as window and level, pan and zoom, and image annotation) capabilities. MobileCT Viewer does not provide image processing functions which are intended to alter the image data (e.g. filtering, multiplanar reconstruction, and 3D reconstruction).
MobileCT Viewer's capabilities include support for viewing medical images from modalities not indicated in Mobile MIMs submission: X-ray. This difference does not alter the intended offect of the device (that is, the display of medical images) and does not raise any different types of safety and effectiveness questions. Information including performance data is provided in this submission to assess device performance in viewing images from these added modalities.
In addition, MobileCT Viewer does not support the following advanced image manipulations: image fusion, multiplanar reconstruction (MPR), maximum intensity projection (MIP), or standard update values (SUV). Consistently, the Indications for Use Statement for MobileCT Viewer excludes the advanced image manipulations.
3
.
| Item | MobileCT | MobileMIM |
|---|---|---|
| Intended Use / Indication for Use | The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals. | |
| MobileCT Viewer provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. | ||
| This device is not to be used for mammography. | The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT and MRI. | |
| Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. | ||
| This device is not to be used for mammography. | ||
| Receive, Store, Retrieve, Display and Process Digital Medical Images | Yes | Yes |
| Display of Clinical Patient Data When No Access to a Workstation | Yes | Yes |
| Image Fusion | No | Yes |
| 3D reconstruction, e.g. Multi-Planar Reconstruction (MPR), Maximum Intensity Projection (MIP) | No | Yes |
| Standard Uptake Value (SUV) | No | Yes |
| Distance Measurements | Yes | Yes |
| Window/Level | Yes | Yes |
| Zoom/Pan | Yes | Yes |
| User Authentication | Yes | Yes |
| Modalities | CT, MRI. X-ray | SPECT, PET, CT, MRI |
| Remote Handheld Viewing Device | Yes | Yes |
| Operating Platform | Yes | Yes |
| Hardware Requirements | the Apple iPad (4th generation, late 2012) | Apple iOS handheld devices |
. . . . . .
TABLE 1: Device Comparison table between new device and predicate
4
23
Part V. 510(k) Summary of Safety and Effectiveness
For a complete discussion of how hazards related to the use of MobileCT Viewer as a diagnostic, review, and analysis tool by trained professionals should be addressed during device development as part of the risk management process, see the Device Use Safety discussion in Part XVI (Software) Chapter 3 (Hazard analysis) of this 510(k) premarket notification. Additionally, a summary of the results of the testion 9.6 and section 9.7) done during the Alpha and Beta development stages demonstrate that the device, when used according to operating instructions, can be used safely and effectively.
Summary of testing
Nephosity, Inc. has performed multiple studies with qualified medical professionals. These medical professional tested MobileCT Viewer by evaluating the image quality of the medical inages of the supported modalities (i.e. CT, MRJ, X-ray ) under different environmental conditions. Results of these studies affirm the diagnostic viewing capabilities of MobileCT Viewer when used as indicated.
Additionally, Nephosity, Inc. has conducted performance and functional testing on the MobileCT Viewer software. In all cases, the software passed its performance requirements and met specifications. A summary of the results of the testion 9.6 and section 9.7) of Part XVI.
No animal or clinical testing was performed.
Conclusion
Based on a comparison between the MobileCT Viewer and the Mobile MIM and on the performance data provided in this premarket notification submission, it is our belief that the new device is as safe and effective as the predicate device, and does not raise different questions of safety and effectiveness than the predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Silver Spring, MD 20993-0002
May 16, 2013
Nephosity, Inc. % Mr. Michael Pan CEO 615 Grant Avenue, 3F SAN FRANCISCO CA 94108
Re: K123082
Trade/Device Name: MobileCT Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II . Product Code: .LLZ Dated: March 30, 2013 Received: April 3. 2013
Dear Mr. Pan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.p)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K123082
Device Name: MobileCT Viewer
Indications for Use:
The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals.
MobileCT Viewer provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm.h.p).
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123082 510(k)
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