(13 days)
Not Found
Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts, and the description of the device's function (computer reconstruction of X-ray transmission data) is a standard CT imaging process that does not inherently require AI/ML.
No
The device is described as an imaging system that produces cross-section images, which is diagnostic in nature, not therapeutic.
Yes
The device is described as producing "cross-section images of head and whole body by computer reconstruction of X-ray transmission data". The production of images from the body is a primary function of diagnostic devices, as these images are then used by medical professionals to diagnose conditions.
No
The intended use clearly describes a system that produces cross-section images using X-ray transmission data, which inherently requires hardware (an X-ray machine and detector) to acquire the data. The description of "computer reconstruction" refers to the software component, but the overall system is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for producing cross-section images of the head and whole body using X-ray transmission data. This is a diagnostic imaging device, not a device that performs tests on biological samples in vitro (outside of the living body).
- Input Imaging Modality: The input is X-ray transmission data, which is a physical imaging modality, not a biological sample.
- Anatomical Site: The device is used on the head and whole body, which are parts of the living organism.
IVD devices are typically used to examine biological samples such as blood, urine, tissue, etc., to diagnose diseases or conditions. This device operates by imaging the internal structure of the body directly.
N/A
Intended Use / Indications for Use
CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
Product codes
90 JAK
Device Description
CT-C3000 Spiral CT Scanner System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head and whole body
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the word "NEUSOFT" in bold, black letters. There is a curved line above the word, starting above the "N" and ending above the "T". The font is sans-serif and appears to be a logo or brand name.
Attachment 2
K 020913
Summary of Safety and Effectiveness
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:
| Trade Name: | CT-C3000 Spiral CT Scanner System |
|---|---|
| Common Name: | CT Scanner |
| 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 |
| UL 187, Standard for safety, X-ray Equipment | |
| IEC60601-1, Medical Electrical Equipment - Part 1: General | |
| Requirements for Safety | |
| Manufacture: | Neusoft Digital Medical System Co.,Ltd |
| No.3-11,Wenhua Road, Heping District, | |
| Shenyang, China | |
| Post Code : 110004 | |
| Distributor: | Neusoft Digital Medical System Co.,Ltd |
| No.3-11, Wenhua Road, Heping District, | |
| Shenyang, China | |
| Post Code : 110004 | |
| Submitter: | Name: Wang Zhiqiang |
| Title: Manager of Quality Management Department | |
| Who maybe contacted | |
| by telephone at 86-24-83665003 | |
| by FAX at 86-24-23782711 | |
| by E-Mail at wangzq@neusoft.com | |
| Summary prepared : Mar 9th , 2002 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 3 2002
Neusoft Digital Medical System Co. % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K020913
Trade/Device Name: CT C3000 Spiral CT Scan System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 18, 2002 Received: March 21, 2002
Dear Mr. Gmelin:
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.
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); 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.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
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Image /page/3/Picture/0 description: The image shows the word "NEUSOFT" in bold, black letters. There is a curved line above the word, which appears to be part of a logo. The font is sans-serif and slightly italicized, giving the word a dynamic appearance. The overall impression is of a company logo or brand name.
510(k)
Attachment 3
Indications for Use
Page 1 of 1
510(k) Number (if Known) K020913
Device Name: CT-C3000 System
Indications for use:
CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
David G. Seymour
(Division Sign-Off) Division of Reproductive, and Radiological Devi 510(k) Numb
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)