Cleared Traditional

K913471 - CIRRUS GAMMA CAMERA

K913471 is the FDA 510(k) clearance for CIRRUS GAMMA CAMERA by Adac Laboratories. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K913471 · Adac Laboratories · Radiology device
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Oct 1991
Decision
79d
Days
Class 2
Risk

K913471 is an FDA 510(k) clearance for the CIRRUS GAMMA CAMERA. 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 October 23, 1991 after a review of 79 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

Submission Details

510(k) Number K913471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date October 23, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
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 K913471.
APEX HELIX - A
K914807 · Elscint, Inc. · Feb 1992
CEQUAL(TM)
K914527 · General Electric Co. · Nov 1991
CARDIOFOCAL COLLIMATOR
K914179 · Siemens Gammasonics, Inc. · 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