Identifiers
- 510(k) Number
- K983764 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Viewpoint Tools Sterrad is an image-assisted surgery system that provides intra-operative orientation and reference using pre-acquired diagnostic patient images. It utilizes trackable surgical instruments, including a Y-probe, guide blocks, and a trackable awl, equipped with infrared emitting diodes (IREDs).
The system is supplied by Philips Medical Systems (Cleveland), Inc. and has been cleared under FDA 510(k) with the clearance number K983764. The product code for this device is HAW. The device is intended for use in neurology and has been reviewed by the Neurology advisory committee.
Frequently asked questions
What is the Viewpoint Tools Sterrad used for?
The Viewpoint Tools Sterrad is used for intra-operative orientation and reference in neurology, utilizing pre-acquired diagnostic patient images.
How is the Viewpoint Tools Sterrad supplied?
The system is supplied by Philips Medical Systems (Cleveland), Inc. and includes trackable surgical instruments such as a Y-probe, guide blocks, and a trackable awl.
What is the regulatory status of the Viewpoint Tools Sterrad?
The Viewpoint Tools Sterrad has been cleared under FDA 510(k) with the clearance number K983764, and is classified under product code HAW.
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: VIEWPOINT TOOLS- STERRAD (K983764) — FDA 510 (k) | Innolitics, K983764 FDA 510 (k) - VIEWPOINT TOOLS- STERRAD, PDF K983764 - Viewpoint Tools- Sterrad, VIEWPOINT TOOLS- STERRAD 510 (k) K983764 - FDA.report, Philips Medical Systems (Cleveland), Inc., et al v. GL Leading ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983764 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K983764 24 fields · synced Oct 6, 2026