Cedara I-Response Cedara PET/CT
510(k) K053301
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053301 | Date3 Feb 2006 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cedara I-Response Cedara PET/CT is a System, Image Processing, Radiological device designed for the integration and analysis of PET (Positron Emission Tomography) and CT (Computed Tomography) imaging data. It enhances diagnostic accuracy by enabling fused PET/CT image reconstruction and interpretation, supporting radiologists and clinicians in evaluating metabolic and anatomical information simultaneously.
This software-based system is intended for use in radiology departments within healthcare facilities, where it processes and displays combined PET/CT scans. Supplied as a standalone application, it requires integration with existing PET/CT imaging systems and is not classified as single-use or reusable. The device holds an FDA 510(k) clearance under product code LLZ, with no third-party review involved, and operates under traditional regulatory pathways.
Other devices from Cedara Software Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Cedara I-Response Cedara PET/CT system in clinical practice?
The Cedara I-Response Cedara PET/CT system is designed to integrate and analyze PET (Positron Emission Tomography) and CT (Computed Tomography) imaging data, enabling radiologists and clinicians to reconstruct and interpret fused PET/CT images. This fusion allows simultaneous evaluation of both metabolic activity (from PET) and anatomical details (from CT), enhancing diagnostic accuracy for conditions requiring comprehensive imaging analysis.
How is the Cedara I-Response Cedara PET/CT system supplied and what are its integration requirements?
The system is supplied as a standalone software application that must be integrated with existing PET/CT imaging systems already in use within radiology departments. It is not a single-use or reusable device, as it operates as a continuous software tool for processing and displaying combined PET/CT scans.
Is the Cedara I-Response Cedara PET/CT system intended for use in specific healthcare settings?
Yes, the device is specifically intended for use in radiology departments within healthcare facilities. Its software-based design requires integration into clinical workflows where PET/CT imaging is performed, ensuring radiologists and clinicians can leverage fused imaging for diagnostic purposes.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?
The Cedara I-Response Cedara PET/CT system received FDA clearance through a 510(k) submission under the traditional regulatory pathway, classified under product code LLZ (Radiology). This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, allowing it to enter the market without third-party review involvement.