Cleared Traditional

K884990 - IMS-3 PICTURE ARCHIVING SYSTEM

K884990 is an FDA 510(k) clearance for IMS-3 PICTURE ARCHIVING SYSTEM, manufactured by The Biomedical Engineering Center. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K884990 · The Biomedical Engineering Center · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
112d
Days
Class 1
Risk

K884990 is an FDA 510(k) clearance for the IMS-3 PICTURE ARCHIVING SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by The Biomedical Engineering Center (Sacramento, US). The FDA issued a Cleared decision on March 23, 1989 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Biomedical Engineering Center devices

FDA 510(k) Submission Details - K884990

510(k) Number K884990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date March 23, 1989
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 34
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K884990.
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · Adac Laboratories · Apr 1990
KODAK EKTASCAN IMAGE MANAGER
K891690 · Eastman Kodak Company · Jun 1989
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
K885327 · Philips Medical Systems North America, Inc. · May 1989
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
K873048 · Eastman Kodak Company · Oct 1987
ERS SYSTEM
K863286 · General Electric Co. · Oct 1986