Cleared Traditional

K923522 - LINAC-BASED STEROTACTIC RADIOSURGERY

K923522 is an FDA 510(k) clearance for LINAC-BASED STEROTACTIC RADIOSURGERY, manufactured by Radionics Software Applications, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K923522 · Radionics Software Applications, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
398d
Days
Class 2
Risk

K923522 is an FDA 510(k) clearance for the LINAC-BASED STEROTACTIC RADIOSURGERY. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Radionics Software Applications, Inc. (Brookline, US). The FDA issued a Cleared decision on August 18, 1993 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Radionics Software Applications, Inc. devices

FDA 510(k) Submission Details - K923522

510(k) Number K923522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date August 18, 1993
Days to Decision 398 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
291d slower than avg
Panel avg: 107d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

All 386
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K923522.
MED-TEC BREAST SUPPORT SYSTEM
K942282 · Medtec, Inc. · Jul 1994
HANDI-FOAM
K935021 · Medtec, Inc. · Apr 1994
VICTOREEN MODEL 530
K931927 · Victoreen, Inc. · Nov 1993
REFIX(TM) SYSTEM
K930279 · Nomos Corp. · Jul 1993
PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM
K924495 · Philips Medical Systems, Inc. · Jun 1993
LCM-2-LINAC COUCH-MOUNT SYSTEM
K924632 · Radionics, Inc. · Apr 1993