Cleared Traditional

K924495 - PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM (FDA 510(k) Clearance)

Jun 1993
Decision
277d
Days
Class 2
Risk

K924495 is an FDA 510(k) clearance for the PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on June 8, 1993, 277 days after receiving the submission on September 4, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K924495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date June 08, 1993
Days to Decision 277 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.5050

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