Cleared Traditional

K162394 - CRC-77tHR

K162394 is the FDA 510(k) clearance for CRC-77tHR by Capintec, Inc.. It is a Class 2 Radiology device (product code KPT) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K162394 · Capintec, Inc. · Radiology device
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Mar 2017
Decision
194d
Days
Class 2
Risk

K162394 is an FDA 510(k) clearance for the CRC-77tHR. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Capintec, Inc. (Florham Park, US). The FDA issued a Cleared decision on March 8, 2017 after a review of 194 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Capintec, Inc. devices

Submission Details

510(k) Number K162394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2016
Decision Date March 08, 2017
Days to Decision 194 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K162394.
CRC PC Smart Chamber K1
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MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp. · Oct 2002
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · Victoreen, Inc. · Jul 1993
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815 · Victoreen, Inc. · Aug 1985
B.D.A.S.
K813065 · General Electric Co. · Dec 1981
DISPENSER, TECHNETIUM, CLINTICHEM
K770515 · Union Carbide Corp. · Apr 1977