510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834611Substantially Equivalent

Singul-Xr Rp Non Screen Med. Film

Cea America Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834611 is the FDA 510(k) clearance record for SINGUL-XR RP NON SCREEN MED. FILM, a class I device, cleared for Cea America Corp. on under FDA product code IWZ (Film, Radiographic). FDA records list 5 510(k) clearances for Cea America Corp., from to . As of , FDA records show no recalls naming K834611.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IWZ Film, Radiographic
Regulation
21 CFR 892.1840
Device class
Class I
Review panel
Radiology
Applicant
Cea America Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWZ

Trailing 12 months

FDA records hold no clearances under product code IWZ in the trailing twelve months.

FDA records show no clearances under product code IWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260