Cleared Traditional

K892358 - PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER

K892358 is the FDA 510(k) clearance for PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER by Adac Laboratories. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K892358 · Adac Laboratories · Radiology device
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Aug 1989
Decision
139d
Days
Class 2
Risk

K892358 is an FDA 510(k) clearance for the PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER. 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 August 23, 1989 after a review of 139 days - within the typical 510(k) review window.

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: 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 Adac Laboratories devices

Submission Details

510(k) Number K892358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date August 23, 1989
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K892358.
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · Siemens Gammasonics, Inc. · May 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · Siemens Gammasonics, Inc. · Apr 1990
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · Shimadzu Medical Systems · Nov 1989
NEUROFOCAL COLLIMATOR
K891266 · Siemens Gammasonics, Inc. · Apr 1989
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
K884349 · Adac Laboratories · Dec 1988
NON-CIRCULAR ORBITING OPTION
K861252 · Siemens Gammasonics, Inc. · Apr 1986