Identifiers
- 510(k) Number
- K885047 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 is a System, Nuclear Magnetic Resonance Imaging device used in radiology. It is a Class II medical device that has received FDA 510(k) clearance as substantially equivalent to a predicate device.
The device is manufactured by Philips Medical Systems (Cleveland), Inc. and has been assigned the product code LNH and regulation number 892.1000. It has received multiple FDA 510(k) clearances, including K885047, with the first clearance granted on March 14, 1989.
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 device used in radiology to produce detailed images of internal body structures for diagnostic purposes.
Who manufactures the Vista MR 2055 HP System?
The Vista MR 2055 HP System is manufactured by Philips Medical Systems (Cleveland), Inc., located in Highland Heights, Ohio, United States.
What regulatory pathway was used for the Vista MR 2055 HP System?
The Vista MR 2055 HP System received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device, with the first clearance granted on March 14, 1989 under K885047.
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 MR 2055 HP SYSTEM (K883482) - FDA 510 (k), K893619 FDA 510 (k) - VISTA MR 2055 HP SYSTEM, VISTA MR 2055 HP SYSTEM (K885047) — FDA 510 (k) | Innolitics, Philips Vista MR 2055 HP - allmed.wiki, VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES (K893739) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K885047 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K885047 24 fields · synced Sep 24, 2026