Cleared Traditional

Astroid Planning App (K173940) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 113
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