Cleared Traditional

K011611 - CARDIOCAM MODEL 9CSY0799

K011611 is an FDA 510(k) clearance for CARDIOCAM MODEL 9CSY0799, manufactured by Danish Diagnostic Development A/S. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K011611 · Danish Diagnostic Development A/S · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
14d
Days
Class 2
Risk

K011611 is an FDA 510(k) clearance for the CARDIOCAM MODEL 9CSY0799. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Danish Diagnostic Development A/S (Horsholm, DK). The FDA issued a Cleared decision on June 8, 2001 after a review of 14 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Danish Diagnostic Development A/S devices

FDA 510(k) Submission Details - K011611

510(k) Number K011611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date June 08, 2001
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 324
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K011611.
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
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · Digirad Corp. · Jun 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001
GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc. · Dec 2000
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
K003264 · Ge Medical Systems F.I. Haifa · Dec 2000