Cleared Special

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 (K021656) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021656 · Nuclear Diagnostics · Radiology device
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Jun 2002
Decision
24d
Days
Class 2
Risk

K021656 is an FDA 510(k) clearance for the HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Nuclear Diagnostics (Stockholm, SE). The FDA issued a Cleared decision on June 13, 2002 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuclear Diagnostics devices

Submission Details

510(k) Number K021656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date June 13, 2002
Days to Decision 24 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 172
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K021656.
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co. · Feb 2003
GE DISCOVERY LS SYSTEM
K023988 · GE Medical Systems · Feb 2003
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · GE Medical Systems · Sep 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001