Cleared Traditional

K061440 - P.D

K061440 is an FDA 510(k) clearance for P.D, manufactured by .Decimal, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K061440 · .Decimal, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
34d
Days
Class 2
Risk

K061440 is an FDA 510(k) clearance for the P.D. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 34 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.

View all .Decimal, Inc. devices

FDA 510(k) Submission Details - K061440

510(k) Number K061440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2006
Decision Date June 27, 2006
Days to Decision 34 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
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

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 161
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K061440.
ACCUSOFT, ACCUSOFT XL
K062032 · Direx Systems Corp. · Oct 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · Accuray Incorporated · Sep 2006
IPLAN RT DOSE
K053584 · Brainlab AG · Jul 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · Varian Medical Systems · Nov 2005
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325 · Accuray Incorporated · Sep 2005