510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833239Substantially Equivalent

Porta. X-Ray Unit Fp220 Scm-1-Etc,

Showa X-Ray Co., Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833239 is the FDA 510(k) clearance record for PORTA. X-RAY UNIT FP220 SCM-1-ETC,, a class II device, cleared for Showa X-Ray Co., Ltd. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list one 510(k) clearance for Showa X-Ray Co., Ltd. As of , FDA records show no recalls naming K833239.

Clearance record

Decision date
Received
(91 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Showa X-Ray Co., Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IZL

Trailing 12 months
7 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20261