(397 days)
Not Found
No
The description focuses on iterative reconstruction techniques and noise reduction levels, which are traditional image processing methods, and does not mention AI or ML.
No
The device is a CT reconstruction software designed to help reduce radiation dose and improve image quality for diagnostic purposes, not to directly treat a disease or condition.
No
ClearView is a CT reconstruction software designed to improve image quality and reduce radiation dose. It processes raw data from a CT scanner to produce images and does not directly interpret or analyze those images for diagnostic purposes. The "Intended Use" section clearly states that "the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution," implying its role in image generation, not diagnosis itself.
Yes
The device is explicitly described as "CT reconstruction software" and its function is to process raw CT data into images. There is no mention of any associated hardware component being 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.
- ClearView's Function: ClearView is described as CT reconstruction software. Its purpose is to process raw data acquired from a CT scanner to create images. It works with the output of an imaging modality (CT), not with biological samples from a patient.
- Intended Use: The intended use clearly states it's for CT reconstruction and helping to reduce radiation dose while maintaining image quality. This is related to the imaging process itself, not the analysis of biological samples.
Therefore, ClearView falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data.
Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.
A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.
ClearView are not intended to be used in CCT and Pilot.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
ClearView reconstruction technology may enable reduction in pixel noise standard deviation and improvement in low contrast resolution. ClearView reconstruction algorithm may allow for reduced mAs in the acquisition of image, thereby it can reduce the dose required.
In clinical practice, the use of ClearView reconstruction may reduce CT patient dose depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.
As a reconstruction option, ClearView can be selected before scanning or after scanning. There are 9 ClearView Levels from 10% to 90%. Users can select t.the level of ClearView that is appropriate for the clinical task being performed. According to the comparison based on the requirements of 21 CFR 807.87, we stated that ClearView reconstruction software is substantially equivalent to the FBP of NeuViz 64 Multi-Slice CT Scanner System.
ClearView is a moderate concern device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.
A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.
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.
NeuViz 64 Multi-Slice CT Scanner System(K121792)
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Neusoft Medical Systems Co., Ltd. % Mr. Tian Yuehui No. 16, Shiji Road Hunnan Industrial Area Shenyang, Liaoning, 110179 CHINA
Re: K133373
Trade/Device Name: ClearView Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 30, 2014 Received: November 3, 2014
Dear Mr. Yuehui:
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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
December 3, 2014
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education 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,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
K133373 510(k) Number (if known) :
Device Name: ClearView
Indications for use:
ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data.
Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.
A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.
ClearView are not intended to be used in CCT and Pilot.
Prescription Use Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Deices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510 (k) -
Page 1 of 1
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Section 6
510(K) Summary
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510(K) Summary
Page 1 of 2
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92
General Information:
| Trade Name: | ClearView |
|---|---|
| Common Name: | ClearView |
| Classification Name: | 21 CFR Part 892.1750 |
| Computed Tomography X-ray System | |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment |
| Standard | |
| Manufacture: | Neusoft Medical Systems Co., Ltd. |
| No.16 Shiji Road, Hunnan Industrial Area, Shenyang, | |
| Liaoning, China, 110179 | |
| Distributor: | Neusoft Medical Systems Co., Ltd. |
| No.16 Shiji Road, Hunnan Industrial Area, Shenyang, | |
| Liaoning, China, 110179 | |
| Submitter: | Contact : Tian Yuehui |
| Title : Manager of Q&R Department | |
| Tel : 86-24-83660646 | |
| Fax : 86-24-83660563 | |
| E-Mail : tianyh@neusoft.com |
Summary prepared : November, 30, 2014
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Page 2 of 2
Safety and Effectiveness information
Intended Uses:
ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.
A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.
ClearView are not intended to be used in CCT and Pilot.
Device Description:
ClearView reconstruction technology may enable reduction in pixel noise standard deviation and improvement in low contrast resolution. ClearView reconstruction algorithm may allow for reduced mAs in the acquisition of image, thereby it can reduce the dose required.
In clinical practice, the use of ClearView reconstruction may reduce CT patient dose depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.
As a reconstruction option, ClearView can be selected before scanning or after scanning. There are 9 ClearView Levels from 10% to 90%. Users can select t.the level of ClearView that is appropriate for the clinical task being performed. According to the comparison based on the requirements of 21 CFR 807.87, we stated that ClearView reconstruction software is substantially equivalent to the FBP of NeuViz 64 Multi-Slice CT Scanner System.
ClearView is a moderate concern device.
Predicated Devices:
NeuViz 64 Multi-Slice CT Scanner System(K121792).
Statement of Substantial Equivalence:
ClearView is a CT reconstruction technology, which is of comparable type and substantially equivalent to the filter back-projection (FBP) that complies with the same or equivalent standards and has the same intended uses. The end user can choose to apply either
ClearView or the filter back-projection (FBP) to the acquired raw data within the image reconstruction module of the NeuViz 64 Multi-Slice CT Scanner System(K121792). Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution.
According to the comparison based on the requirements of 21 CFR 807.87, we stated
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Image /page/6/Picture/0 description: The image shows the word "Neusoft" in a bold, sans-serif font. The text is a dark blue color, contrasting with the white background. The word is presented in a simple, clean design.
that ClearView reconstruction software is substantially equivalent to the FBP of
NeuViz 64 Multi-Slice CT Scanner System.