Quantim 2000I Digital Image Analysis System
by Quantitative Cardiac Systems (Qcs), Inc.
510(k) K892711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892711 | Date14 Dec 1989 | 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- Withdrawn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, 20 Sep 2026
The Quantim 2000I Digital Image Analysis System is a radiology device classified under product code LLZ, designed for digital image analysis of cardiac X-ray studies. It functions as a diagnostic tool to quantify and analyze cardiac structures and functions from radiographic images, aiding in the assessment of cardiac conditions. This system falls under the category of digital imaging equipment used in radiology settings for precise diagnostic evaluation.
The device is supplied by Quantitative Cardiac Systems (Qcs), Inc. and is intended for use in radiology departments, where it processes and analyzes digital X-ray images. It is a reusable system, not single-use, and operates within standard radiology environments without MRI-specific constraints. The system adheres to regulatory standards as evidenced by its FDA 510(k) clearance (K892711), granted under the Traditional pathway in 1989. Storage and handling follow general radiology equipment protocols, ensuring proper calibration and maintenance for accurate diagnostic results.
Questions
AI-generated answers, 20 Sep 2026
What specific type of medical imaging does the Quantim 2000I Digital Image Analysis System analyze, and how is it used in a clinical setting?
The Quantim 2000I is designed exclusively for analyzing cardiac X-ray studies, specifically to quantify and assess cardiac structures and functions from radiographic images. Clinicians use it in radiology departments to process digital X-rays, enabling precise diagnostic evaluations of heart conditions by measuring parameters like chamber sizes, wall motion, and overall cardiac performance.
Is the Quantim 2000I a single-use or reusable device, and what maintenance considerations should be taken into account?
The Quantim 2000I is a reusable system, not intended for single-use. Since it operates within standard radiology environments, proper calibration and routine maintenance are critical to ensure accuracy and reliability. Follow manufacturer guidelines for servicing, as deviations could compromise diagnostic precision.
How is the device regulated, and what does its FDA clearance indicate about its intended use?
The Quantim 2000I holds an FDA 510(k) clearance (K892711), granted under the Traditional pathway in 1989, with a decision code of SESE (Substantially Equivalent). This clearance confirms the device meets regulatory standards for digital imaging equipment in radiology (product code LLZ) and is intended for quantitative analysis of cardiac X-rays, not for general radiology or MRI applications.
What storage and handling protocols should be followed for the Quantim 2000I to ensure optimal performance?
The device follows standard radiology equipment protocols for storage and handling, as it is not MRI-specific. Ensure it is stored in a controlled environment to protect from physical damage or environmental factors. Regular calibration and adherence to manufacturer instructions are essential to maintain accuracy, as the system relies on precise digital analysis of cardiac X-rays.