Cleared Traditional

K850838 - CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW

K850838 is an FDA 510(k) clearance for CLINICOMP RDMS RADIONUCLIDE DISPENSING ..., manufactured by Clinicomp, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K850838 · Clinicomp, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
209d
Days
Class 2
Risk

K850838 is an FDA 510(k) clearance for the CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Clinicomp, Inc. (Huntington Woods, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 209 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 Clinicomp, Inc. devices

FDA 510(k) Submission Details - K850838

510(k) Number K850838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date September 26, 1985
Days to Decision 209 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 107d · This submission: 209d
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 11
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K850838.
PET-DOSE
K042746 · Comecer S.R.L. · Nov 2004
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