Cleared Special

K024137 - JUPITER PROCESSING AND REVIEW WORKSTATION (FDA 510(k) Clearance)

K024137 · Ge Medical Systems, Inc. · Radiology device

Jan 2003

Decision

30d

Days

Class 2

Risk

K024137 is an FDA 510(k) clearance for the JUPITER PROCESSING AND REVIEW WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on January 15, 2003, 30 days after receiving the submission on December 16, 2002.

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

Submission Details

510(k) Number	K024137 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 2002
Decision Date	January 15, 2003
Days to Decision	30 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF