Cleared Traditional

K963936 - ACCESSPOINT

K963936 is an FDA 510(k) clearance for ACCESSPOINT, manufactured by Biosound, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K963936 · Biosound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
181d
Days
Class 1
Risk

K963936 is an FDA 510(k) clearance for the ACCESSPOINT, MED E-MAIL, DICOM READER. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 31, 1997 after a review of 181 days - an extended review cycle.

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 Biosound, Inc. devices

FDA 510(k) Submission Details - K963936

510(k) Number K963936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date March 31, 1997
Days to Decision 181 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 107d · This submission: 181d
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 11
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K963936.
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