Cleared Special

K052159 - AIDA COMPACT II SYSTEM (FDA 510(k) Clearance)

K052159 · KARL STORZ Endoscopy-America, Inc. · Radiology device

Sep 2005

Decision

29d

Days

Class 2

Risk

K052159 is an FDA 510(k) clearance for the AIDA COMPACT II SYSTEM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 7, 2005, 29 days after receiving the submission on August 9, 2005.

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

Submission Details

510(k) Number	K052159 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 09, 2005
Decision Date	September 07, 2005
Days to Decision	29 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Statement