Cleared Traditional

K962792 - LINAC SCALPEL TREATMENT PLANNING SYSTEM
(FDA 510(k) Clearance)

K962792 · Surgical Navigation Technologies, Inc. · Radiology

Nov 1996

Decision

118d

Days

Class 2

Risk

K962792 is an FDA 510(k) clearance for the LINAC SCALPEL TREATMENT PLANNING SYSTEM. This device is classified as a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE).

Submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 12, 1996, 118 days after receiving the submission on July 17, 1996.

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

Submission Details

510(k) Number	K962792 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 1996
Decision Date	November 12, 1996
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF