Cleared Traditional

K002444 - PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206

K002444 is an FDA 510(k) clearance for PRECISION DOSIMETRY ELECTROMETER, manufactured by Sun Nuclear Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K002444 · Sun Nuclear Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
70d
Days
Class 2
Risk

K002444 is an FDA 510(k) clearance for the PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sun Nuclear Corp. (Melbourne, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002444

510(k) Number K002444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date October 18, 2000
Days to Decision 70 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 703
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K002444.
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
K003330 · Aktina Medical Physics Corp. · Jan 2001
INVAC
K002608 · Duncan Hynd Associates, Ltd. · Nov 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · Surgical Navigation Technologies, Inc. · Oct 2000
PREFERENCE TREATMENT SYSTEM
K001833 · Northwest Medical Physics Equipment, Inc. · Sep 2000
INVIDOS
K002051 · Scanditronix Medical AB · Sep 2000
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
K001052 · Med-Tec,Inc. · Aug 2000
K002444 · PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
Download PDF FDA Summary Sun Nuclear Corp.