Cleared Traditional

K092639 - INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP (FDA 510(k) Clearance)

K092639 · GE Medical Systems SCS · Radiology device

Dec 2009

Decision

97d

Days

Class 2

Risk

K092639 is an FDA 510(k) clearance for the INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems SCS (Waukesha, US). The FDA issued a Cleared decision on December 2, 2009, 97 days after receiving the submission on August 27, 2009.

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

Submission Details

510(k) Number	K092639 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 2009
Decision Date	December 02, 2009
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF