Cleared Special

SPOT PRO (220V), MODEL 131.099 (K022741) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022741 · Nucletron Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
66d
Days
Class 2
Risk

K022741 is an FDA 510(k) clearance for the SPOT PRO (220V), MODEL 131.099. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 66 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. 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.

View all Nucletron Corporation devices

Submission Details

510(k) Number K022741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date October 24, 2002
Days to Decision 66 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 91
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K022741.
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · Siemens Medical Solutions USA, Inc. · Jun 2010
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · Siemens Medical Solutions USA, Inc. · Nov 2002
ACQPLAN
K974770 · Philips Medical Systems (Cleveland), Inc. · Sep 1998