Cleared Special

K002553 - DS DS I-SERIES

K002553 is an FDA 510(k) clearance for DS DS I-SERIES, manufactured by Smv America. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 29-day FDA review.

K002553 · Smv America · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
29d
Days
Class 2
Risk

K002553 is an FDA 510(k) clearance for the DS DS I-SERIES. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Smv America (Twinsburg, US). The FDA issued a Cleared decision on September 15, 2000 after a review of 29 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 - K002553

510(k) Number K002553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date September 15, 2000
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 472
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K002553.
ALLEGRO TB, ALLEGRO N
K003434 · Adac Laboratories · Nov 2000
ECAT PET SCANNER
K002715 · Cti Pet Systems, Inc. · Oct 2000
WACKERS-LIU CQ SOFTWARE
K002229 · Eclipse Systems, Inc. · Oct 2000
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
K001681 · Smv America · Aug 2000
MEDICAL IMAGE MERGE (MIM)
K001276 · Syntermed, Inc. · Jul 2000
UNICORN MODEL SYS0630
K001888 · Danish Diagnostic Development A/S · Jun 2000
K002553 · DS DS I-SERIES
Download PDF FDA Summary Smv America