Cleared Traditional

K000395 - EINSTEIN PROCESSING AND REVIEW WORKSTATION (FDA 510(k) Clearance)

K000395 · Ge Medical Systems F.I. Haifa · Radiology device

May 2000

Decision

86d

Days

Class 2

Risk

K000395 is an FDA 510(k) clearance for the EINSTEIN 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 F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on May 3, 2000, 86 days after receiving the submission on February 7, 2000.

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

Submission Details

510(k) Number	K000395 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 2000
Decision Date	May 03, 2000
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF