(52 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard image manipulation and visualization tools.
No.
The device is for display and visualization of medical images to assist in diagnosis, not for therapeutic purposes.
Yes
The device is intended to "assist in diagnosis" by allowing users to retrieve, process, render, and review medical image files.
Yes
The device description explicitly states "Table is a volumetric imaging software" and "The software runs in Windows operating systems and visualizes medical imaging data on the computer screen." It does not mention any accompanying hardware components that are part of the medical device itself, relying on standard PC hardware.
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 "Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI." It processes and displays images, not biological samples.
- Intended Use: The intended use is for reviewing and assisting in diagnosis based on medical images, not laboratory test results.
Therefore, Table falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, and assist in diagnosis, utilizing standard PC hardware.
This device is not indicated for mammography use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning. zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, clinicians, referring physicians and other qualified individuals
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)
Bench testing of the software with predicate software was performed by evaluation of images rendered by Table and predicate software. This testing and evaluation included testing of measurement tools in both predicate and subject software and was evaluated by an expert in the field of radiology. This testing confirms that Table is as effective as its predicates in its ability to perform its essential functions of measurement and rendering of DICOM data.
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
K 140093
Page 1 of 3
5. 510K Summary
:
| MAR - 7 2014 | |
|---|---|
| Submitter | Anatomage Inc. |
| 111 N. Market Street #800 | |
| San Jose, CA 95113 | |
| Phone: (408) 885-1474 | |
| Fax: (408) 295-9786 | |
| Regulatory Contact Person | Mike Mendez, Quality Manager |
| Phone Number: (408) 885-1474 ext 119 | |
| Cell: (415) 370-9794 | |
| Device Name | Table |
| 510(k) Preparation Date | January 07, 2014 |
| Common Name | System, Image Processing, Radiological |
| Classification | Class II |
| Classification Name | Imaging Processing System, LLZ, 21 CFR 892.2050 |
| Product Code | LLZ, 21 CFR 892.2050 |
| Device Description | Table is a volumetric imaging software designed specifically for |
| clinicians, doctors, physicians, and other qualified medical | |
| professionals. The software runs in Windows operating systems | |
| and visualizes medical imaging data on the computer screen. | |
| Users are able to examine anatomy on a computer screen and use | |
| software tools to move and manipulate images by turning. | |
| zooming, flipping, adjusting contrast and brightness, cutting, and | |
| slicing using either touch control or a mouse. The software also | |
| has the ability to perform measurements of angle and length. | |
| There are multiple tools to annotate and otherwise mark areas of | |
| interest on the images. Additionally, Table has the ability to | |
| demonstrate pathology examples of patient data for educational | |
| purposes. | |
| Intended Use | Table is a software application used for the display and 3D |
| visualization of medical image files from scanning devices such as | |
| CT and MRI. It is intended for use by radiologists, clinicians, | |
| referring physicians and other qualified individuals to retrieve, | |
| process, render, review, and assist in diagnosis, utilizing standard | |
| PC hardware. |
1
Equivalent Devices
Technological Characteristic
This device is not indicated for mammography use. K123519 Anatomage, InVivoDental
visualized as volume or 2D images.
Table and the predicate device are standalone software. These software devices are designed to be installed on standard off-theshelf x86 processor based computers running the Windows operating system. DICOM data from medical imaging devices are
A difference between Table and the predicate software is the touch interface that has been designed to complement a standard interface of mouse and keyboard. This interface is designed to provide a convenient way of using the software but does not change the functionality of the device from a system designed for keyboard and mouse controlled only. Also, the Table is designed to run on 64 bit operating systems only while InVivoDental is able to run on both 64 and 32 bit. While In VivoDental can perform volume and area measurements. Table performs the essential linear and angular measurement only. In VivoDental is designed with specialized tools for dental implant planning. Table does not have this feature. InVivoDental has tools for looking at custom cross-sectional troughs. This dental feature is not included in Table. Table cannot superimpose images nor perform cephalometric analysis. Table cannot save case workups, nor does it display imbedded patient information.
Testing confirmed that the software is stable and operating as designed.
The following quality assurance measures were applied to the development of the system:
Risk Analvsis
- · Requirements Reviews
· Design Reviews
· Performance testing (Verification)
· Safety testing (Verification)
· Final acceptance testing (Validation)
· Bench testing to compare with predicate software
Testing confirmed that the software is stable and operating as designed. Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels.
Bench testing of the software with predicate software was performed by evaluation of images rendered by Table and
Non-Clinical Test Results
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K140093
Page 3 of 3
predicate software. This testing and evaluation included testing of measurement tools in both predicate and subject software and was evaluated by an expert in the field of radiology. This testing confirms that Table is as effective as its predicates in its ability to perform its essential functions of measurement and rendering of DICOM data.
Based on the intended use, product, performance, and testing information provided in this notification. the subject device has been shown to be substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate device.
Summary
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Anatomage, Inc. % Mr. Mike Mendez Quality Manager 111 N. Market Street #800 SAN JOSE CA 95113
Re: K140093
Trade/Device Name: Table Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 7, 2014 Received: January 14, 2014
Dear Mr. Mendez:
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, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Mendez
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.lda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entilled, "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.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
4. Indications For Use Statement
510(k) Number (if known): K140093
Device Name: __ Table
Indications for Use:
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, and assist in diagnosis, utilizing standard PC hardware.
This device is not indicated for mammography use.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
$m_{i} \cdot \beta$
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR) Evaluation and Safety 510(k) K140093
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