510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000209Substantially Equivalent

Dose 1

Scanditronix Wellhofer North America, Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000209 is the FDA 510(k) clearance record for DOSE 1, a class II device, cleared for Scanditronix Wellhofer North America on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list one 510(k) clearance for Scanditronix Wellhofer North America. As of , FDA records show no recalls naming K000209.

Clearance record

Decision date
Received
(207 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Scanditronix Wellhofer North America 3111 Stage Post Dr., Suite 105, Bartlett TN
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