Cleared Special

K021656 - HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4

K021656 is an FDA 510(k) clearance for HERMES HDAQ ACQUISITION STATION AND HER..., manufactured by Nuclear Diagnostics. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 24-day FDA review.

K021656 · Nuclear Diagnostics · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K021656

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 470
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K021656.
MOBILE MILLENNIUM MG SYSTEM
K022240 · Ge Medical Systems, Inc. · Aug 2002
MPOWER, MODEL 712 SERIES
K022001 · Positron Corp. · Jul 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · Nuclear Cardiology Systems, Inc. · Jun 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · Syntermed, Inc. · Apr 2002
NEUROSPECTQUAD GAMMA CAMERA
K013353 · Nuclear Cardiology Systems, Inc. · Mar 2002
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K014033 · Syntermed, Inc. · Feb 2002
K021656 · HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
Download PDF FDA Summary Nuclear Diagnostics