Identifiers
- 510(k) Number
- K945580 FDA 510(k)
- FDA Product Code
- IZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1620 FDA 510(k)
- Regulation Number
- 892.1620 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DSP Option is a device classified as a Camera, X-Ray, Fluorographic, Cine Or Spot, used in radiology. It is a software option that enhances imaging capabilities for medical diagnostic purposes.
The DSP Option is supplied by Philips Medical Systems (Cleveland), Inc. and is a Class II device with FDA 510K clearance. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the DSP Option used for in medical imaging?
The DSP Option is a software device that enhances imaging capabilities for medical diagnostic purposes in radiology. It is classified as a Camera, X-Ray, Fluorographic, Cine Or Spot device, improving the quality and functionality of medical imaging systems.
How is the DSP Option supplied and what is its classification?
The DSP Option is supplied by Philips Medical Systems (Cleveland), Inc. It is a Class II medical device with FDA 510K clearance, indicating it has been determined to be substantially equivalent to existing devices on the market.
Is the DSP Option single-use or reusable, and does it require special storage conditions?
The device data does not specify whether the DSP Option is single-use or reusable. Additionally, no information regarding sterility, MRI safety, or specific storage conditions is provided in the available documentation.
What regulatory route does the DSP Option follow and when was it cleared?
The DSP Option received FDA 510K clearance through the traditional review process on January 30, 1995. It was reviewed by the Radiology Advisory Committee (RA) and assigned product code IZJ, with K number K945580.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945580 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K945580 24 fields · synced Oct 6, 2026