510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970137Substantially Equivalent

Exl-12Sp,12dp,15dp,20dp Linac

Mitsubishi Electronics America, Inc., Conshohocken PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970137 is the FDA 510(k) clearance record for EXL-12SP,12DP,15DP,20DP LINAC, a class II device, cleared for Mitsubishi Electronics America, Inc. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 3 510(k) clearances for Mitsubishi Electronics America, Inc., from to . As of , FDA records show no recalls naming K970137.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Mitsubishi Electronics America, Inc. 1 Fayette St., Suite 100, Conshohocken 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