Cleared Traditional

K982855 - DIGIRAD 2020TC SPECT IMAGING SYSTEM

K982855 is an FDA 510(k) clearance for DIGIRAD 2020TC SPECT IMAGING SYSTEM, manufactured by Digirad Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982855 · Digirad Corp. · Radiology device
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Nov 1998
Decision
90d
Days
Class 2
Risk

K982855 is an FDA 510(k) clearance for the DIGIRAD 2020TC SPECT IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Digirad Corp. (San Diego, US). The FDA issued a Cleared decision on November 4, 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 Digirad Corp. devices

FDA 510(k) Submission Details - K982855

510(k) Number K982855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date November 04, 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.

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 372
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K982855.
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
FORTE
K982911 · Adac Laboratories · Nov 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · Siemens Medical Solutions USA, Inc. · Oct 1998
AUTOMATED MEDICAL REPORT WRITER
K981553 · Woodson and Associates, LLC · Sep 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · Toshiba America Medical Systems, In.C · Sep 1998