Scanner, CT 0450
by Pfizer Medical Systems, Inc. 510(k)
Active
510(k) K781752
Overview
A CT scanner is a medical imaging device that uses X-ray technology to produce detailed cross-sectional images of the body. The Scanner, CT 0450 is a computed tomography scanner designed for diagnostic imaging applications.
This device is supplied as a reusable system intended for use in radiology settings. It received FDA 510(k) clearance (K781752) on November 3, 1978, and is classified under product code JAK. No information regarding sterility, MRI safety, sizes, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781752 | Date3 Nov 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Pfizer Medical Systems, Inc.
Questions
What is the Scanner, CT 0450 used for?
The Scanner, CT 0450 is a computed tomography scanner designed for diagnostic imaging applications, using X-ray technology to produce detailed cross-sectional images of the body in radiology settings.
Is the Scanner, CT 0450 reusable or single-use?
The Scanner, CT 0450 is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and maintenance, as indicated in the device description for radiology environments.
How was the Scanner, CT 0450 cleared for market?
The Scanner, CT 0450 received FDA 510(k) clearance under submission K781752 on November 3, 1978, based on a determination of substantial equivalence to a legally marketed predicate device.