Cleared Traditional

K982911 - FORTE

K982911 is the FDA 510(k) clearance for FORTE by Adac Laboratories. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982911 · Adac Laboratories · Radiology device
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Nov 1998
Decision
90d
Days
Class 2
Risk

K982911 is an FDA 510(k) clearance for the FORTE. 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 November 16, 1998 after a review of 90 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 K982911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1998
Decision Date November 16, 1998
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 K982911.
BEACON, MODEL 211060
K983948 · Philips Medical Systems (Cleveland), Inc. · Apr 1999
POSITRON OPTION, MODEL NSCO-050A
K983514 · Toshiba America Medical Systems, In.C · Dec 1998
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · Toshiba America Medical Systems, In.C · Dec 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · Siemens Medical Solutions USA, Inc. · Oct 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · Toshiba America Medical Systems, In.C · Sep 1998
VANTAGE 3.0 INSYNCH
K981291 · Adac Laboratories · Jun 1998