510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K972816Substantially Equivalent

Advanced Treatment Planning System

Advanced Radiation Therapy Systems, Inc., King Oof Prussia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972816 is the FDA 510(k) clearance record for ADVANCED TREATMENT PLANNING SYSTEM, a class II device, cleared for Advanced Radiation Therapy Systems, Inc. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list one 510(k) clearance for Advanced Radiation Therapy Systems, Inc. As of , FDA records show no recalls naming K972816.

Clearance record

Decision date
Received
(178 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Advanced Radiation Therapy Systems, Inc. 430 Jean Way, King Oof Prussia PA
510(k) summary
Summary
Third party review
No

Clearances, product code IYE

Trailing 12 months
16 clearances under product code IYE in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260