Cleared Traditional

K844620 - BDS-3 BEAM DATA SCANNER

K844620 is an FDA 510(k) clearance for BDS-3 BEAM DATA SCANNER, manufactured by Varian Assoc., Inc.. The device is a Class 1 Radiology device with product code LHO cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K844620 · Varian Assoc., Inc. · Radiology device
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Jul 1985
Decision
216d
Days
Class 1
Risk

K844620 is an FDA 510(k) clearance for the BDS-3 BEAM DATA SCANNER. Classified as Instrument, Quality-assurance, Radiologic (product code LHO), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 216 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1940 - 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 Varian Assoc., Inc. devices

FDA 510(k) Submission Details - K844620

510(k) Number K844620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date July 01, 1985
Days to Decision 216 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 107d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

LHO Device Classification - Class 1, General Controls

Product Code LHO Instrument, Quality-assurance, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1940
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 - LHO Instrument, Quality-assurance, Radiologic

Devices cleared under the same product code (LHO) and FDA review panel - the closest regulatory comparables to K844620.
MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
K853754 · Victoreen, Inc. · May 1986
MULTI PURPOSE MODEL 76-903
K860260 · Victoreen, Inc. · May 1986
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
K860100 · Victoreen, Inc. · Apr 1986
RFA-7 RADIATION FIELD ANALYZER
K845007 · Varian Assoc., Inc. · Jul 1985