Cleared Special

K071396 - CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS

K071396 is an FDA 510(k) clearance for CRC 25 SERIES (CRC 25R, 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 38-day FDA review.

K071396 · Capintec, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
38d
Days
Class 2
Risk

K071396 is an FDA 510(k) clearance for the CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS. 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 28, 2007 after a review of 38 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 - K071396

510(k) Number K071396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date June 28, 2007
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 K071396.
CRC PC WITH SMART CHAMBER
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K090296 · Biodex Medical Systems, Inc. · Feb 2009
PET-DOSE
K042746 · Comecer S.R.L. · Nov 2004
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K030066 · Nuclear Associates · Aug 2003
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp. · Oct 2002
K071396 · CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
Download PDF FDA Summary Capintec, Inc.