Cleared Traditional

K162394 - CRC-77tHR

K162394 is an FDA 510(k) clearance for CRC-77tHR, manufactured by Capintec, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K162394

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.

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 9
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K162394.
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K931657 · Victoreen, Inc. · Jul 1993