Cleared Traditional

K110601 - SENTINELLA 102 (FDA 510(k) Clearance)

K110601 · General Equipment For Medical Imaging, S.A. · Radiology device
Mar 2011
Decision
16d
Days
Class 1
Risk

K110601 is an FDA 510(k) clearance for the SENTINELLA 102. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).

Submitted by General Equipment For Medical Imaging, S.A. (Valencia, ES). The FDA issued a Cleared decision on March 18, 2011, 16 days after receiving the submission on March 2, 2011.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K110601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date March 18, 2011
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYX - Camera, Scintillation (gamma)
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.1100