Cleared Traditional

K961871 - FLOUROSPOT T.O.P. (FDA 510(k) Clearance)

K961871 · Siemens Medical Solutions USA, Inc. · Radiology device

Jul 1996

Decision

77d

Days

Class 2

Risk

K961871 is an FDA 510(k) clearance for the FLOUROSPOT T.O.P.. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on July 31, 1996, 77 days after receiving the submission on May 15, 1996.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K961871 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 15, 1996
Decision Date	July 31, 1996
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF