Lorad M-III Mammographic X-Ray System
by Lorad Corp.
510(k) K934625
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934625 | Date28 Jan 1994 | 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- Withdrawn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
- Full name
- Lorad M-III
- 510(k) Number
- FDA Product Code
- IZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1710
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Lorad M-III is a Mammographic X-Ray System, designed for digital or analog breast imaging to detect and evaluate breast abnormalities. It operates as a standalone unit, incorporating a C-arm and control console to produce high-resolution mammograms, aiding in the early detection and diagnosis of breast cancer.
This device is intended for use in radiology departments and has received FDA 510(k) clearance (K934625) under the Traditional 510(k) Review Process, classified as a Class II medical device. Supplied as a reusable system, it adheres to regulatory standards outlined in 21 CFR 892.1710 and is manufactured by Lorad Corp. in Danbury, Connecticut. No specific sterility or MRI safety information is provided in the regulatory data.
Other devices from Lorad Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of breast imaging can the Lorad M-III perform, and how does it differ from standard analog systems?
The Lorad M-III is designed for both digital and analog breast imaging, allowing flexibility depending on clinical needs. Unlike purely analog systems, it produces high-resolution mammograms through a standalone C-arm and control console, which enhances image clarity for detecting and evaluating breast abnormalities such as tumors or calcifications. This dual-capability supports early detection and diagnosis of breast cancer while maintaining compatibility with existing workflows.
Is the Lorad M-III a single-use or reusable device, and what maintenance considerations should be noted?
The Lorad M-III is supplied as a reusable system, meaning it is intended for repeated use in radiology departments after proper cleaning and maintenance. Since it is not sterile, it must be handled according to facility protocols for reusable medical devices. Regular servicing and calibration are essential to ensure consistent imaging quality and compliance with regulatory standards (e.g., 21 CFR 892.1710).
What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?
The Lorad M-III received FDA 510(k) clearance (K934625) under the Traditional 510(k) Review Process, classified as a Class II medical device. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for mammographic imaging. Clinicians can rely on this clearance to confirm its suitability for breast cancer screening and diagnostic use in radiology departments.
Are there multiple models or configurations of the Lorad M-III, and how can I identify the correct one for my facility?
The Lorad M-III appears to have multiple FEI numbers (e.g., 3001722928, 3009470597) and registration numbers, which may correspond to different configurations or serial batches. These identifiers are used for regulatory tracking and inventory management. To ensure compatibility, verify the exact model or variant with Lorad Corp. or consult your facility’s equipment records, as specifications like C-arm adjustments or software versions may vary slightly.