Cleared Traditional

K242748 - Oncospace

K242748 is an FDA 510(k) clearance for Oncospace, manufactured by Oncospace, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K242748 · Oncospace, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
211d
Days
Class 2
Risk

K242748 is an FDA 510(k) clearance for the Oncospace. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Oncospace, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 11, 2025 after a review of 211 days - an extended review 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: 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 Oncospace, Inc. devices

FDA 510(k) Submission Details - K242748

510(k) Number K242748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2024
Decision Date April 11, 2025
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 K242748.
Dose+ (1.0)
K250064 · Mvision AI OY · Sep 2025
RT Elements (4.5)
K250440 · Brainlab AG · Jun 2025
RayCare (2024A SP1)
K242992 · RaySearch Laboratories AB (PUBL) · Apr 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
K240398 · RaySearch Laboratories AB (PUBL) · Apr 2025
ART-Plan+ (v.3.0.0)
K242822 · Therapanacea Sas · Feb 2025
ARIA Radiation Therapy Management System (18.1)
K242463 · Varian Medical Systems, Inc. · Dec 2024