Image Post-Processing Techniques
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980831 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 Image Post-Processing Techniques is a device used in Radiology for Nuclear Magnetic Resonance Imaging. It is classified as a System. The device has a product code of LNH and a regulation number of 892.1000.
The device is supplied by Philips Medical Systems (Cleveland), Inc. and has been issued an FDA 510K clearance, specifically K980831. The device is intended for use in a medical setting, with its specific use and storage determined by the manufacturer's instructions and relevant medical guidelines.
Frequently asked questions
What is the Image Post-Processing Techniques device used for?
The device is used in Radiology for Nuclear Magnetic Resonance Imaging, intended for use in a medical setting.
What type of clearance does the device have?
The device has been issued an FDA 510K clearance, specifically K980831, indicating it is substantially equivalent to a predicate device.
How is the device supplied and stored?
The device is supplied by Philips Medical Systems and its storage is determined by the manufacturer's instructions and relevant medical guidelines.
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: Philips Image Post-Processing Techniques - allmed.wiki, Philips Medical Systems (Cleveland), Inc. - DeviceClearance, PDF Philips Medical Systems Technologies Ltd. ℅ Prithul Bom Most ..., Philips Medical Systems (Cleveland), Inc. et al v. Buan et al, 1 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980831 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K980831 24 fields · synced Oct 6, 2026