Philips DSI System Release 3.2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K920793 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 Philips DSI System Release 3.2 is a Camera, X-Ray, Fluorographic, Cine or Spot device, classified under 21 CFR 892.1620 for radiology applications. It is designed for capturing dynamic and static radiographic images, including cine and spot imaging, to support diagnostic procedures in fluoroscopy.
This system is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional review pathway, classified as Class II. Supplied as a reusable medical device, it adheres to regulatory standards for imaging equipment in clinical environments. The product code IZJ identifies its submission category under the Radiology specialty.
Frequently asked questions
What types of imaging does the Philips DSI System Release 3.2 support, and where is it typically used?
The Philips DSI System Release 3.2 is designed to capture both dynamic and static radiographic images, including cine (moving images) and spot (still images) imaging. It is specifically intended for use in radiology settings to assist with diagnostic procedures during fluoroscopy, which is commonly used for real-time X-ray imaging of internal structures.
Is the Philips DSI System Release 3.2 a single-use or reusable device, and how is it classified under regulatory standards?
The Philips DSI System Release 3.2 is supplied as a reusable medical device, meaning it is intended for repeated use in clinical environments after proper cleaning, maintenance, and sterilization. It is classified under 21 CFR 892.1620 as a Class II device, which is the standard regulatory classification for imaging equipment like cameras, X-ray, fluorographic, cine, or spot devices.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Philips DSI System Release 3.2 received FDA clearance through the Traditional 510(k) review pathway, meaning its safety and effectiveness were determined by comparing it to a legally marketed predicate device. This clearance confirms it meets regulatory standards for use in radiology settings, ensuring it is suitable for capturing dynamic and static radiographic images during diagnostic procedures.
How is this device categorized in terms of medical specialty, and what does that imply for its intended applications?
The Philips DSI System Release 3.2 falls under the Radiology specialty as per its product code (IZJ) and regulatory classification. This categorization implies it is specifically designed for use in radiology departments, where it supports diagnostic imaging tasks such as fluoroscopy, cine radiography, and spot imaging to visualize internal structures in real time or as still frames.
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 DSI SYSTEM RELEASE 3.2 - fda.innolitics.com, PDF K920793 - Philips Dsi System Release 3, PHILIPS DSI SYSTEM RELEASE 3.2 510(k) K920793 - FDA.report, Global home | Philips, Philips Dsi Release 3.2 - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920793 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K920793 24 fields · synced Sep 19, 2026