510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934478Substantially Equivalent

Alpha Stereo

Instrumentarium Corp., Tuusula, Finland, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934478 is the FDA 510(k) clearance record for ALPHA STEREO, a class II device, cleared for Instrumentarium Corp. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 20 510(k) clearances for Instrumentarium Corp., from to . As of , FDA records show no recalls naming K934478.

Clearance record

Decision date
Received
(504 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Instrumentarium Corp. P.O. Box 20 (Nahkelantie 160), Tuusula, Finland, FI
510(k) summary
Statement
Third party review
No

Clearances, product code IZH

Trailing 12 months

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

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