Cleared Traditional

ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000

K984405 · Intracom Corp. · Radiology

Feb 1999

Decision

61d

Days

Class 1

Risk

About This 510(k) Submission

K984405 is an FDA 510(k) clearance for the ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000, a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by Intracom Corp. (Sunnyvale, US). The FDA issued a Cleared decision on February 8, 1999, 61 days after receiving the submission on December 9, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K984405 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 1998
Decision Date	February 08, 1999
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — General Controls
CFR Regulation	21 CFR 892.2010
Definition	Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.