Cleared Special

K141413 - CRC PC WITH SMART CHAMBER

K141413 is an FDA 510(k) clearance for CRC PC WITH SMART CHAMBER, manufactured by Capintec, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Special 510(k) pathway after a 29-day FDA review.

K141413 · Capintec, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
29d
Days
Class 2
Risk

K141413 is an FDA 510(k) clearance for the CRC PC WITH SMART CHAMBER. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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 - K141413

510(k) Number K141413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2014
Decision Date June 27, 2014
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.

KPT Device Classification - Class 2, Special Controls

Product Code KPT Calibrator, Dose, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1360
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 - KPT Calibrator, Dose, Radionuclide

All 31
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K141413.
CRC PC Smart Chamber K1
K192199 · Capintec, Inc. · Sep 2019
CRC-77tHR
K162394 · Capintec, Inc. · Mar 2017
Veenstra Instruments VDC-506 Dose Calibrator
K142325 · Comecer Netherlands B.V. · Sep 2014
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
K101452 · Capintec, Inc. · Aug 2010
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
K090296 · Biodex Medical Systems, Inc. · Feb 2009
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
K071396 · Capintec, Inc. · Jun 2007
K141413 · CRC PC WITH SMART CHAMBER
Download PDF FDA Summary Capintec, Inc.