Cleared Traditional

K051392 - BTI-SCAN, VERSION 4.0 (FDA 510(k) Clearance)

K051392 · B.T.I. Biotechnology Institute, Sl. · Radiology device

Jun 2005

Decision

33d

Days

Class 2

Risk

K051392 is an FDA 510(k) clearance for the BTI-SCAN, VERSION 4.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by B.T.I. Biotechnology Institute, Sl. (Minano Menor, Alava, ES). The FDA issued a Cleared decision on June 29, 2005, 33 days after receiving the submission on May 27, 2005.

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

Submission Details

510(k) Number	K051392 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 27, 2005
Decision Date	June 29, 2005
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF