Cleared Traditional

K894998 - MODIFIED POSICAM SYSTEM MODEL 6.5

K894998 is an FDA 510(k) clearance for MODIFIED POSICAM SYSTEM MODEL 6.5, manufactured by Positron. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K894998 · Positron · Radiology device
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Nov 1989
Decision
86d
Days
Class 2
Risk

K894998 is an FDA 510(k) clearance for the MODIFIED POSICAM SYSTEM MODEL 6.5. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Positron (Houston, US). The FDA issued a Cleared decision on November 2, 1989 after a review of 86 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 Positron devices

FDA 510(k) Submission Details - K894998

510(k) Number K894998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date November 02, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
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 248
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K894998.
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
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · Adac Laboratories · Aug 1989
NEUROFOCAL COLLIMATOR
K891266 · Siemens Gammasonics, Inc. · Apr 1989
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
K884349 · Adac Laboratories · Dec 1988