CT Scanner ND 8000
510(k) K781040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781040 | Date18 Jul 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
A CT scanner is a medical imaging device that uses X-ray technology to produce detailed cross-sectional images of the body. The CT Scanner ND 8000 is a computed tomography scanner designed for diagnostic imaging in clinical settings.
This device is used in radiology departments for diagnostic imaging procedures. It is supplied as a reusable system requiring installation and maintenance by qualified personnel. The device received FDA 510(k) clearance under K781040 on July 18, 1978, and is classified under product code JAK with advisory committee review in radiology.
Other devices from Cgr Medical Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the CT Scanner ND 8000 used for?
The CT Scanner ND 8000 is used for diagnostic imaging procedures in radiology departments, producing detailed cross-sectional images of the body using X-ray technology to support clinical diagnosis.
How is the CT Scanner ND 8000 supplied and maintained?
The device is supplied as a reusable system that requires installation and ongoing maintenance by qualified personnel, meaning it is not a single-use or disposable unit but intended for repeated clinical use over time.
What regulatory pathway was used for the CT Scanner ND 8000?
The CT Scanner ND 8000 received FDA 510(k) clearance under submission K781040 on July 18, 1978, based on a determination of substantial equivalence to a legally marketed predicate device.