Models 190GE-64/191GE-64/192GE-64/193GE-64
510(k) K914536
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914536 | Date27 Nov 1991 | 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- Withdrawn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
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Nuclear Magnetic Resonance Imaging System, classified as a Class II medical device. It generates detailed images of the internal structures of the body using magnetic fields and radio waves, enabling diagnostic evaluation of soft tissues, organs, and skeletal systems for clinical assessment.
The Models 190GE-64/191GE-64/192GE-64/193GE-64 are intended for use in radiology settings and have received FDA 510(k) clearance under the Traditional pathway, determined to be Substantially Equivalent to a predicate device. These systems are not single-use and are designed for reusable applications in MRI-compatible environments, adhering to regulatory standards outlined under 892.1000. No specific sterility or storage instructions are provided in the data.
Other devices from Medical Advances, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these MRI systems designed for single-use or reusable applications in a clinical setting?
These MRI systems (Models 190GE-64/191GE-64/192GE-64/193GE-64) are explicitly designed for reusable applications in MRI-compatible environments. The device data does not mention single-use, and the regulatory classification (Class II) aligns with durable medical equipment intended for repeated use in radiology settings.
What types of internal structures can this MRI system evaluate, and why is that important for diagnostic purposes?
This Nuclear Magnetic Resonance Imaging System is capable of generating detailed images of soft tissues, organs, and the skeletal system, enabling comprehensive diagnostic evaluations. This capability is critical for identifying abnormalities in non-bony structures (e.g., tumors, inflammation, or vascular issues) that may not be visible on X-rays or CT scans, thus improving clinical assessment accuracy.
How should these MRI systems be stored, and are there any special handling requirements mentioned in the data?
The provided data does not specify any special storage instructions for these MRI systems. However, as reusable medical devices, they should be stored in a clean, dry environment, protected from physical damage, and maintained according to the manufacturer’s (Medical Advances, Inc.) guidelines to ensure optimal performance and compliance with regulatory standards (e.g., 892.1000).
What regulatory pathway was used for FDA clearance, and how does this affect the device’s intended use?
These MRI systems received FDA 510(k) clearance under the Traditional pathway, determined to be Substantially Equivalent (SESE) to a predicate device. This means the device’s safety and effectiveness were compared to an existing approved MRI system, confirming it meets regulatory standards for diagnostic imaging in radiology settings. The clearance does not define clinical indications but confirms compliance for use in MRI-compatible environments.