Cleared Traditional

K911275 - POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM

K911275 is an FDA 510(k) clearance for POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM, manufactured by Positron. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K911275 · Positron · Radiology device
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May 1991
Decision
48d
Days
Class 2
Risk

K911275 is an FDA 510(k) clearance for the POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM. 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 May 9, 1991 after a review of 48 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 - K911275

510(k) Number K911275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1991
Decision Date May 09, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 107d · This submission: 48d
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 K911275.
CIRRUS GAMMA CAMERA
K913471 · Adac Laboratories · Oct 1991
MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM
K913630 · Siemens Gammasonics, Inc. · Oct 1991
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · Siemens Gammasonics, Inc. · Jun 1991
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