510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834465Substantially Equivalent

Series of Diagnostic Phantoms

Cirs, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834465 is the FDA 510(k) clearance record for SERIES OF DIAGNOSTIC PHANTOMS, a class I device, cleared for Cirs, Inc. on under FDA product code IXG (Phantom, Anthropomorphic, Radiographic). FDA records list one 510(k) clearance for Cirs, Inc. As of , FDA records show no recalls naming K834465.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IXG Phantom, Anthropomorphic, Radiographic
Regulation
21 CFR 892.1950
Device class
Class I
Review panel
Radiology
Applicant
Cirs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IXG

Trailing 12 months

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

FDA records show no clearances under product code IXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXG, 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