(37 days)
The NeuViz Dual systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
The NeuViz Dual Multi-slice CT Scanner System -NeuViz Dual (H) and NeuViz Dual (L) - are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
The NeuViz Dual systems are whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of 2 slices simultaneously. There are two variants with different tube capacity: NeuViz Dual (H) and NeuViz Dual (L). The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
This document is a 510(k) premarket notification for the NeuViz Dual Multi-slice CT Scanner System. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Based on the provided information, the acceptance criteria and study details are not present in this summary. This document primarily focuses on establishing substantial equivalence to a predicate device (CT-C3000DUAL and CT-C2800DUAL Family) rather than presenting a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details from the provided text.
The closest information available is the "Statement of Substantial Equivalence," which argues that the NeuViz Dual systems are "of comparable type and substantially equivalent to the CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems (K041542) that comply with the same or equivalent standards and has the same intended uses." This implies that the device is deemed acceptable if it meets the same standards and performance as the predicate device, but no specific performance metrics or a study demonstrating this are present in the provided text.
{0}------------------------------------------------
510(k)
Attachment 1 Summary of Safety and Effectiveness
24
Page 1 of 2
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
General Information:
| Device Name: | NeuViz Dual Multi-slice CT Scanner System |
|---|---|
| Classification Name: | 21 CFR Part 892.1750Computed Tomography X-ray System |
| Model Name | NeuViz Dual (H); NeuViz Dual (L) |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray EquipmentStandard |
| Manufacture: | PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.Neusoft Park, Hun Nan Industrial Area, Shenyang 110179,P.R.China |
| Distributor: | NEUSOFT MEDICAL SYSTEMS CO., LTD.No.3-11,Wenhua Road, Heping District,Shenyang, P.R.ChinaPost Code : 110004 |
| Submitter: | Contact : TianyanfangTitle : Manager of Q&R DepartmentTel : 86-24-83660649Fax : 86-24-83780480E-Mail : Tianyanfang@neusoft.com |
Summary prepared : September 10th, 2006
{1}------------------------------------------------
Safety and Effectiveness information
Intended Uses:
The NeuViz Dual systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
Device Description:
The NeuViz Dual systems are whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of 2 slices simultaneously. There are two variants with different tube capacity: NeuViz Dual (H) and NeuViz Dual (L). The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
Predicated Device:
CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems (K041542)
Statement of Substantial Equivalence:
The NeuViz Dual systems are of comparable type and substantially equivalent to the CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems (K041542) that comply with the same or equivalent standards and has the same intended uses. Both of these system use on-board high frequency High-Voltage generator to generate X-radiation from X-ray tube. The X-ray transmission data is detected by the solid-state detector and is reconstructed by the computer which has an interactive user interface. Both of these devices produce two dimensional image and 3D image that can be filmed or electronically stored for future review.
Page 2 of 2
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 8 2006
Neusoft Medical Systems Co., Ltd. c/o Mr. Tamas Borsai TÜV Rheinland of North America 12 Commerce Road NEWTOWN-CT- 06470
Re: K062451
Trade/Device Name: NeuViz Dual Multi-slice CT Scanner System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 12, 2006 Received: September 13, 2006
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 70(x) promatice is substantially equivalent (for the indications for referenced above and have determined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicate and anyants and adouices that use stated in the encrosule/ to regally manuced processor in the Medical Devices that prior io May 26, 1970, the chacallent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, MAA). You mov have been reclassified in accordance will and proven application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (PMA). The parent therefore, market the device, subject to the general controls provisions of the general therefore, market the device, subject to the general vonn, and registration, list in the fulters on controls provisions of the riot morade requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematke If your device is classince (see above) into entrols. Existing major regulations affecting your Approval), it may be subject to such adentonal vontons, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Odde of I concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.
Protecting and Promoting Public Health
{3}------------------------------------------------
Page 2 -
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); 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.
This letter will allow your o begin marketing your device in your-Scation 510(k) rms retter notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Attachment 2 Indications for Use
Page 1 of 1
510(k) Number (if known): K062451
Device Name: NeuViz Dual Multi-slice CT Scanner System
Indications for Use:
The NeuViz Dual Multi-slice CT Scanner System -NeuViz Dual (H) and NeuViz Dual (L) - are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use
Nancy Brogdon
(Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K062451
§ 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.