Vista MR 2055 HP System and 2055 Upgrades
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K893675 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vista MR 2055 HP System and 2055 Upgrades is a nuclear magnetic resonance imaging system used for diagnostic imaging in radiology. It is designed to produce detailed images of internal body structures for medical evaluation and diagnosis.
The system is manufactured by Philips Medical Systems (Cleveland), Inc. and has received FDA 510(k) clearance as substantially equivalent. It is a Class II device regulated under product code LNH, with authorization number K893675. The system is supplied with various components as indicated by the multiple FEI numbers and registration numbers provided in the device data.
Frequently asked questions
What is the Vista MR 2055 HP System used for?
The Vista MR 2055 HP System is a nuclear magnetic resonance imaging system used for diagnostic imaging in radiology. It produces detailed images of internal body structures for medical evaluation and diagnosis.
What is the regulatory status of the Vista MR 2055 HP System?
The system has received FDA 510(k) clearance as substantially equivalent. It is a Class II device regulated under product code LNH with authorization number K893675.
Who manufactures the Vista MR 2055 HP System?
The Vista MR 2055 HP System is manufactured by Philips Medical Systems (Cleveland), Inc., located at 5500 Avion Park Dr., Highland Heights, OH 44143.
What components are included with the Vista MR 2055 HP System?
The system is supplied with various components as indicated by the multiple FEI numbers and registration numbers provided in the device data, though specific components are not detailed in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vista – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K893675 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K893675 24 fields · synced Oct 6, 2026