Cleared Traditional

K173940 - Astroid Planning App

K173940 is an FDA 510(k) clearance for Astroid Planning App, manufactured by .Decimal, LLC. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K173940 · .Decimal, LLC · Radiology device
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Optimized for regulatory review, auditing and printing
May 2018
Decision
140d
Days
Class 2
Risk

K173940 is an FDA 510(k) clearance for the Astroid Planning App. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by .Decimal, LLC (Sanford, US). The FDA issued a Cleared decision on May 15, 2018 after a review of 140 days - within the typical 510(k) review window.

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: 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 .Decimal, LLC devices

FDA 510(k) Submission Details - K173940

510(k) Number K173940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date May 15, 2018
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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 148
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K173940.
Monaco RTP System
K183037 · Elekta, Inc. · Dec 2018
3D Bolus Software
K180289 · 3D Bolus, Inc. · Jul 2018
Eclipse Treatment Planning System
K181145 · Varian Medical Systems, Inc. · May 2018
RayStation 7
K180379 · RaySearch Laboratories AB (PUBL) · Apr 2018
Prelude
K180308 · Medcom GmbH · Mar 2018
syngo.via RT Image Suite
K173635 · Siemens Medical Solutions USA, Inc. · Jan 2018