510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953227Substantially Equivalent

Casper

Northwest Medical Physics Center, Lynnwood WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953227 is the FDA 510(k) clearance record for CASPER, a class II device, cleared for Northwest Medical Physics Center on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 6 510(k) clearances for Northwest Medical Physics Center, from to . As of , FDA records show no recalls naming K953227.

Clearance record

Decision date
Received
(140 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Northwest Medical Physics Center 21031 67th Ave. W., Lynnwood WA
510(k) summary
Statement
Third party review
No

Clearances, product code IXI

Trailing 12 months
1 clearance under product code IXI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260