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RadioCameras System Head/Neck Application

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994355

by Surgical Navigation Technologies, Inc.

Identifiers

510(k) Number
K994355 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RadioCameras System Head/Neck Application is a medical device intended for use in radiology. It is classified as a Class II device under FDA regulation number 892.5050.

The device received FDA 510(k) clearance (K994355) on March 22, 2000, and is substantially equivalent to a predicate device. It is manufactured by Surgical Navigation Technologies, Inc. and is used in clinical settings for head and neck imaging applications.

Frequently asked questions

What is the RadioCameras System Head/Neck Application used for?

The RadioCameras System Head/Neck Application is intended for use in radiology, specifically for head and neck imaging applications in clinical settings, as stated in its device description and classification under FDA regulation number 892.5050.

Who manufactures the RadioCameras System Head/Neck Application and when was it cleared by the FDA?

The RadioCameras System Head/Neck Application is manufactured by Surgical Navigation Technologies, Inc. and received FDA 510(k) clearance (K994355) on March 22, 2000, as documented in the device data.

What regulatory classification and product code apply to the RadioCameras System Head/Neck Application?

The device is classified as a Class II medical device under FDA regulation number 892.5050 and has the product code IYE, as specified in the provided device data.

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: RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION (K994355) — FDA 510(k ..., RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION 510(k)… - FDA.report, PDF K994355 - Radiocameras System Head/Neck Application, Surgical Navigation Technologies, Inc. FDA 510 (k) Products (1996-2000)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgical Navigation Technologies, Inc.

Sources (1)

  • FDA 510(k) K994355 24 fields · synced Sep 24, 2026