Mediq Version 1.0
by Clario Medical Imaging, Inc.
510(k) K052963
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052963 | Date5 Dec 2005 | 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- Withdrawn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, 1 Oct 2026
MEDIQ VERSION 1.0 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from imaging data.
It is supplied as a software package for use in radiology settings to analyze multi-modality digital radiology images including CT, MR, X-Ray, PET, and Nuclear Medicine. Input consists of single or multi-slice datasets. The device received FDA 510(k) clearance under K052963 and is classified under product code LLZ.
Other devices from Clario Medical Imaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What types of imaging data can MEDIQ VERSION 1.0 analyze?
MEDIQ VERSION 1.0 accepts digital radiology datasets from CT, MR, X‑Ray, PET, and Nuclear Medicine. It can process both single‑slice and multi‑slice studies, allowing radiologists to evaluate dynamic changes across a wide range of imaging modalities.
How is the software supplied and installed in a radiology department?
The product is delivered as a software package that can be installed on standard workstation computers used in radiology settings. Installation follows the manufacturer’s instructions and integrates with existing picture‑archiving and communication systems to import image datasets for analysis.
Is MEDIQ VERSION 1.0 a single‑use or reusable product?
As a software application, MEDIQ VERSION 1.0 is reusable; the same licensed installation can be used repeatedly for multiple patient studies without any consumable components. Ongoing use depends on maintaining the software license and complying with any update requirements.
What regulatory pathway did MEDIQ VERSION 1.0 follow for market entry?
The device received FDA 510(k) clearance (K052963) under the traditional clearance pathway, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance permits commercial distribution in the United States for its intended imaging analysis functions.