Pfizer PZ-CT Scanner
by Pfizer Medical Systems, Inc. 510(k)
Active
510(k) K801446
Overview
The Pfizer PZ-CT Scanner is a computed tomography (CT) system designed for radiographic imaging of internal body structures. As a system for X-ray tomography, it generates cross-sectional images to assist in the diagnosis and evaluation of medical conditions by providing detailed visualisation of tissues and organs. This device falls under the classification of a medical imaging system, specifically within the radiology specialty.
The scanner is supplied as a reusable medical device and is intended for use in clinical radiology settings. It operates under the regulatory framework of the FDA, having received a 510(k) clearance (K801446) under the product code JAK, with a decision of Substantially Equivalent (SESE) in 1980. No specific sterility or single-use requirements are noted; however, standard hospital protocols for reusable medical imaging equipment apply. The device is classified as Class II under FDA regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801446 | Date28 Jul 1980 | 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- Withdrawn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 Pfizer PZ-CT Scanner designed for?
The Pfizer PZ-CT Scanner is a computed tomography (CT) system specifically designed to generate cross-sectional radiographic images of internal body structures. These images help clinicians diagnose and evaluate medical conditions by providing detailed visualization of tissues and organs, making it a critical tool in radiology settings.
Is the Pfizer PZ-CT Scanner single-use or reusable?
The Pfizer PZ-CT Scanner is supplied as a reusable medical device. As with all reusable medical imaging equipment, it must adhere to standard hospital protocols for cleaning, disinfection, and maintenance to ensure safety and performance between uses.
What regulatory clearance does the Pfizer PZ-CT Scanner hold?
The Pfizer PZ-CT Scanner received FDA 510(k) clearance under the product code JAK with a decision of Substantially Equivalent (SESE) in 1980. This clearance confirms its compliance with FDA regulations for use as a medical imaging system in radiology.
Does the Pfizer PZ-CT Scanner require sterility for use?
The device data does not specify sterility requirements for the Pfizer PZ-CT Scanner. Since it is a reusable system, standard hospital protocols for reusable medical imaging equipment—such as cleaning, disinfection, and sterilization where applicable—should be followed to maintain safety and functionality.
What type of facility is the Pfizer PZ-CT Scanner intended for?
The Pfizer PZ-CT Scanner is intended for use in clinical radiology settings, where detailed imaging of internal structures is required. Its design and regulatory clearance support its application in hospitals, diagnostic centers, or other healthcare environments where CT imaging is performed.