Cleared Traditional

K884349 - ADAC VIEWPOINT (ADDITIONAL SOFTWARE)

K884349 is an FDA 510(k) clearance for ADAC VIEWPOINT (ADDITIONAL SOFTWARE), manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K884349 · Adac Laboratories · Radiology device
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Dec 1988
Decision
71d
Days
Class 2
Risk

K884349 is an FDA 510(k) clearance for the ADAC VIEWPOINT (ADDITIONAL SOFTWARE). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adac Laboratories devices

FDA 510(k) Submission Details - K884349

510(k) Number K884349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date December 22, 1988
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 374
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K884349.
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · Shimadzu Medical Systems · Nov 1989
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · Adac Laboratories · Aug 1989
NEUROFOCAL COLLIMATOR
K891266 · Siemens Gammasonics, Inc. · Apr 1989
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
K875378 · Shimadzu Precision Instruments, Inc. · Nov 1988
NON-CIRCULAR ORBITING OPTION
K861252 · Siemens Gammasonics, Inc. · Apr 1986
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
K802801 · General Electric Co. · Jan 1981