Cleared Traditional

DIGIRAD 2020TC SPECT IMAGING SYSTEM (K982855) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982855 · Digirad Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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 148
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K982855.
E.CAM COMPUTER
K992731 · Siemens Medical Solutions USA, Inc. · Nov 1999
BEACON-P, MODEL 211059
K992335 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
BEACON, MODEL 211060
K983948 · Philips Medical Systems (Cleveland), Inc. · Apr 1999
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · Siemens Medical Solutions USA, Inc. · Oct 1998
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc. · Sep 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · Siemens Medical Solutions USA, Inc. · Sep 1997