510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K865100Substantially Equivalent

Tissue-Equivalent Breast Simulator

Computerized Imaging Reference Systems, Inc., Norfolk VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K865100 is the FDA 510(k) clearance record for TISSUE-EQUIVALENT BREAST SIMULATOR, a class I device, cleared for Computerized Imaging Reference Systems, Inc. on under FDA product code IXF (Test-Pattern, Radiographic). FDA records list 2 510(k) clearances for Computerized Imaging Reference Systems, Inc., from to . As of , FDA records show no recalls naming K865100.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IXF Test-Pattern, Radiographic
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Applicant
Computerized Imaging Reference Systems, Inc. 2488b Almeda Ave., Norfolk VA
Third party review
No

Clearances, product code IXF

Trailing 12 months

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

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