(186 days)
No
The summary describes image processing and analysis tools, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on traditional validation methods and measurement accuracy, not AI/ML specific metrics.
No
The device is a pre-operative planning and post-operative evaluation tool, not one that directly treats or prevents a disease or condition.
No
This device is described as a "non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation." It provides tools for image processing, segmentation, measurement, and planning, but it does not directly diagnose disease or medical conditions. Its primary function is to aid in planning and evaluation, not diagnosis itself.
Yes
The device is described as a "non-invasive postprocessing application" that processes CT image data and provides tools for planning and evaluation. The description focuses entirely on software functionalities and does not mention any accompanying hardware components that are part of the device itself. While it uses input from a CT scanner (hardware), the device being cleared is the software application.
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 this device is a "non-invasive postprocessing application" that processes "CT (computed tomography) image data." It assists medical professionals with planning and evaluating procedures based on medical images, not on analysis of biological samples.
- Intended Use: The intended use is for "assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures," all of which are based on imaging data.
The device is a medical image processing software intended for use in clinical settings for procedural planning and evaluation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:
- . The software processes CT (computed tomography) image data to provide 3D segmentation of heart structures and vessels relevant to approach planning.
- The user can review the 2D and 3D images to select and plan the delivery path. .
- The user can determine C-arm angles for use during the procedure. ●
- The user can verify and adjust the results of segmentation and cross-section measurements. .
- The software provides visualization techniques such as volume rendering, MIP, MPR and curved . MPR.
- . The user can identify and edit contours and the centerline automatically or manually.
- The user can generate a report with relevant approach planning data and measurements for device . sizing.
- The software can provide visualization of calcium. ●
- . The user can generate tortuosity calculations along a centerline.
Product codes
LLZ
Device Description
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
It allows cardiologists, radiologists and clinical specialists to select patient CT studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. It provides assessment and measurement of different structures of the heart and vessels relevant to approach planning. It provides simple techniques to assess the feasibility of a trans-apical, iliac, or subclavian approach to heart structures for replacement or repair procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (computed tomography) image data
Anatomical Site
aortic valve, aortic root, heart structures and vessels, ventricles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: The software allows cardiologists, radiologists and clinical specialists to select patient CT studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. It provides assessment and measurement of different structures of the heart and vessels relevant to approach planning.
Where Used (Hospital, Home, Ambulance, etc.): Hospital
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
External validation included external cardiologists and radiologists evaluating 70 TAVR cases. Each user felt that the automated segmentation within the application enabled an accurate 3D representation of the relevant anatomy. The users also felt the automated oblique provided an accurate starting point for determining the annulus valve plane. All of the users were able to review the 2D and 3D images, verify and correct the results of segmentations and initialization, create measurements, and generate reports.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Measurements and orientations in Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, as well as the accuracy of orientation markers within Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summarv
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.
| Purpose of | Vital Images, Inc. hereby submits this traditional 510(k) to provide
notification submission of our new Vitrea CT Transcatheter Aortic Valve
Replacement (TAVR) Planning application within our already cleared
Vitrea platform. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission: | |
Submitter: Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN 55343-4414
2134213 Establishment Registration:
Contact Person: lan Nemerov Vice President, General Counsel and Secretary Phone : 952 - 487 - 9622 Fax: 952 - 487 - 9510 E-mail: inemerov@vitalimages.com
510(k) Type: Traditional
Summary Date: August 21, 2012
Device Name
Trade Name: Vitrea CT Transcatheter Aortic Valve Replacement Planning Picture Archiving and Communications System Common Name: Classification Name: System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ)
Predicate Device: Pie Medical Imaging B.V., 3mensio Workstation (K120367)
Device Description:
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
It allows cardiologists, radiologists and clinical specialists to select patient CT studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. It provides assessment and measurement of different structures of the heart and vessels relevant to approach planning. It provides simple techniques to assess the feasibility of a trans-apical, iliac, or subclavian approach to heart structures for replacement or repair procedures.
Intended Use / Indications for Use:
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
1
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:
- The software processes CT (computed tomography) image data to provide 3D segmentation of . heart structures and vessels relevant to approach planning.
- . The user can review the 2D and 3D images to select and plan the delivery path.
- The user can determine C-arm angles for use during the procedure. .
- The user can verify and adjust the results of segmentation and cross-section measurements. ●
- The software provides visualization techniques such as volume rendering, MIP, MPR and . curved MPR.
- . The user can identify and edit contours and the centerline automatically or manually.
- The user can generate a report with relevant approach planning data and measurements for ● device sizing.
- . The software can provide visualization of calcium.
- . The user can generate tortuosity calculations along a centerline.
Technological Characteristics Comparison with the Predicate Device:
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a noninvasive post-processing application for the Vitrea platform to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning leverages the basic functionality and technology of the existing 510(k) cleared Vitrea platform (K071331). It is an advanced application that extends the functionality of the platform for specific uses. The intended use of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures) is substantially equivalent to the cleared intended use of Pie Medical Imaging B.V. 3mensio Workstation [K120367] (assessment of structures of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgerv).
The below technological comparison table shows the equivalence between Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning and the predicate device.
| Vitrea CT Transcatheter Aortic Valve
Replacement (TAVR) Planning
(Submission Subject) | Pie Medical Imaging B.V.,
3mensio Workstation (K120367)
(Predicate Device) | Noted
Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Target Population: | | |
| It is intended for a patient who is a candidate
for an Aortic Valve (AV) replacement
through TAVR procedures.
The software enables assessment and
measurement of aortic valve and related
ventricles. It provides simple techniques to
assess the feasibility of a trans-apical, iliac
(transfemoral), or subclavian approach to
structures for replacement or repair
procedures. | Same
3mensio Structural Heart enables
assessment and measurement of different
structures of the heart, e.g. aortic valve,
mitral valve, and ventricles. It provides
simple techniques to assess the feasibility of
a trans-apical, transfemoral (iliac), or
subclavian approach to structures for
replacement or repair procedures. | None |
| | | |
| | | |
| | | |
| Vitrea CT Transcatheter Aortic Valve
Replacement (TAVR) Planning | Pie Medical Imaging B.V.,
3mensio Workstation (K120367) | Noted
Differences |
| (Submission Subject) | (Predicate Device) | |
| Intended Users: | | |
| The software allows cardiologists,
radiologists and clinical specialists to select
patient CT studies from various data
sources, view them, and process the images
with the help of a comprehensive set of
tools. It provides assessment and
measurement of different structures of the
heart and vessels relevant to approach
planning. | Same
3mensio Workstation is a software solution
that is intended to provide cardiologists,
radiologists and clinical specialists additional
information to aid them in reading and
interpreting DICOM-compliant medical
images of structures of the heart and
vessels. | None |
| Anatomical Sites: | | |
| The software enables assessment and
measurement of aortic valve and related
ventricles. It provides simple techniques to
assess the feasibility of a trans-apical, iliac
(transfemoral), or subclavian approach to
structures for replacement or repair
procedures. | Same
3mensio Structural Heart enables
assessment and measurement of different
structures of the Heart, e.g. aortic valve,
mitral valve, and ventricles. It provides
simple techniques to assess the feasibility of
a trans-apical, transfemoral or subclavian
approach to structures for replacement or
repair procedures. | None |
| Where Used (Hospital, Home, Ambulance, etc.) | | |
| Hospital | Hospital | None |
| Human Factors | | |
| The software is designed for use on a
radiology workstation. | The software is designed for use on a
radiology workstation. | None |
| Use of Contrast | | |
| The software requires contrast enhanced
CTA images. | The software requires contrast enhanced
CTA images. | None |
| DICOM Standard Compliance: | | |
| The software processes DICOM-compliant
CT image data. | Same
3mensio Workstation software processes
DICOM-compliant CT image data. | None |
| Vitrea CT Transcatheter Aortic Valve
Replacement (TAVR) Planning
(Submission Subject) | Pie Medical Imaging B.V.,
3mensio Workstation (K120367)
(Predicate Device) | Noted
Difference |
| Image Processing: | | |
| Segmentation:
The software provides segmentation, which
can be manually adjusted, of the ascending
aorta for aortic root measurement. | Same
3mensio Structural Heart's Aortic Root
analysis tool provides segmentation, which
can be manually adjusted, of the ascending
aorta for aortic root measurements. | None |
| Centerline:
The software's vessel analysis tool provides
a centerline, which can be manually
adjusted, of the vessels relevant to
treatment planning. | Same
3mensio Workstation provides a centerline
detection of vessels, which can be manually
adjusted. | None |
| Image Display: | | |
| The software provides an option to display
vascular anatomy in stretched MPR,
orthogonal, multi-dimensional, curved MPR,
oblique, MIP, and MinIP views. | Same
3mensio Workstation provides many
visualization and image reconstruction
techniques which also include stretched
MPR, orthogonal, multi-dimensional, curved
MPR, oblique, MIP, and MinIP views. | None |
| The software provides a 3D view. | Same
3mensio Workstation provides a 3D view. | None |
| Image Assessment: | | |
| C-arm Angles:
The software provides C-arm angles, which
can be utilized to determine the best
approach to access the anatomy during the
surgery. | Same
3mensio Workstation provides C-arm
angulation calculations, which can be
utilized to determine the best approach to
access the anatomy during the surgery. | None |
| Tools: | Same | None |
| The software provides tools to measure
angle, minimum diameter, length, and area
parameters for device sizing and approach
planning. | 3mensio Workstation provides tools to
measure angle, diameter, length, and area
parameters for device sizing and approach
planning. | |
| Calcification:
The software can visualize calcium in the
aortic root during iliac (transfemoral) access
approach, by using existing Vitrea platform
functionality. | Same
3mensio Workstation provides stretched
view option to visualize calcification during
transfemoral approach. | None |
| Vitrea CT Transcatheter Aortic Valve
Replacement (TAVR) Planning
(Submission Subject) | Pie Medical Imaging B.V.,
3mensio Workstation (K120367)
(Predicate Device) | Noted
Differences |
| Stenosis: | Same
3mensio Workstation enables user to | None |
| The software enables user to visualize and
assess of stenosis by using existing Vitrea
platform's Vessel Probe functionality
(K071331). | visualize and assess of stenosis. | |
| Aneurysms: | Same | None |
| The software enables user to visualize and
assess of aneurysms by using existing
Vitrea platform's Vessel Probe functionality
(K071331). | 3mensio Workstation enables user to
visualize and assess of aneurysms. | |
| Annulus Plane: | Same | None |
| The software provides tools for determining
and manually adjusting the annulus valve
plane. | 3mensio Workstation Structural Heart
module's Aortic Root feature provides Aortic
Root Analysis tool to determine and
manually adjust the annulus plane. | |
| Approach Planning: | Same | None |
| The software provides procedure to
complete following approach planning:
Iliac (transfemoral) access | 3mensio Workstation structure heart
module's aortic root feature provides
following approach planning: | |
| ●
Subclavian access
Trans-apical planning
● | Transfemoral approach, which talks
about iliac access
Subclavian approach
Apex approach, which talks about
●
Trans-apical approach planning | |
| | | |
| Distribute Findings: | | |
| The software provides tools to generate
reports to distribute findings. | Same | None |
| | 3mensio Workstation provides reporting
tools to distribute findings. | |
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Summary of Non-Clinical Tests:
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning was designed, and tested according to written procedures that included applying risk management. Testing included verification, validation, and evaluation of previously acquired medical images.
The following quality assurance measures were applied to the development of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning:
- Risk analysis .
- . Requirements reviews
- Design reviews t
- Performance testing (Verification)
- Safety testing (Verification) ●
- . Simulated use testing (Validation)
5
Verification:
The software verification team had a primary goal of assuring that software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.
Validation:
The software validation team had a primary goal of assuring that software conforms to user needs and intended uses. The result of the validation team's efforts was evidence, produced by workflow testing, that system requirements and features were implemented, reviewed and met.
Internal Validation:
The software validation team provided internal validation of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning. Internal validation included internal beta testing and internal user acceptance testing.
External Validation:
During external validation of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, external cardiologists and radiologists evaluated 70 TAVR cases. Each user felt that the automated segmentation within the application enabled an accurate 3D representation of the relevant anatomy. The users also felt the automated oblique provided an accurate starting point for determining the annulus valve plane. All of the users were able to review the 2D and 3D images, verify and correct the results of segmentations and initialization, create measurements, and generate reports.
The software was designed, developed and tested according to written procedures. Software testing was completed to ensure the new feature operates according to its requirements and without impact to existing functionality.
Summary of Clinical Tests:
The subject of this traditional 510(k) notification, Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
-
Confidentiality .
Vitrea platform relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine. -
Integrity .
Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields. -
. Availability
Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained. -
. Accountability
Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
6
Measurement Accuracy:
Measurements and orientations in Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, as well as the accuracy of orientation markers within Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning.
Performance Standard:
No applicable mandatory performance standards or special controls exist for this device.
Substantial Equivalence:
The intended use and technological characteristics of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning are substantially equivalent to the intended use and technological characteristics of the predicate device.
Conclusion:
The testing reported in this 510(k) establishes that Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is substantial equivalent to the predicate device and is safe and effective for its intended use.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a double-stranded snake winding around a staff.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2013
Vital Images, Inc. % Mr. Ian Nemerov Vice President, General Counsel & Secretary 5850 Opus Parkway, Suite #300 MINNETONKA MN 55343
Re: K122578
Trade/Device Name: Vitrea CT Transcatheter Aortic Valvue Replacement (TAVR) Planning Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 21, 2013 Received: January 22, 2013 ·
Dear Mr. Nemerov:
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. Isting 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.
8
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
FDA
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K122578
Device Name: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Indications for Use:
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:
- . The software processes CT (computed tomography) image data to provide 3D segmentation of heart structures and vessels relevant to approach planning.
- The user can review the 2D and 3D images to select and plan the delivery path. .
- The user can determine C-arm angles for use during the procedure. ●
- The user can verify and adjust the results of segmentation and cross-section measurements. .
- The software provides visualization techniques such as volume rendering, MIP, MPR and curved . MPR.
- . The user can identify and edit contours and the centerline automatically or manually.
- The user can generate a report with relevant approach planning data and measurements for device . sizing.
- The software can provide visualization of calcium. ●
- . The user can generate tortuosity calculations along a centerline.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
FDA
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
Page 1 of 1
510 (k) K122578