510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923786Substantially Equivalent

Polydoros Xs50 and Sx80

Siemens Medical Solutions USA, Inc., Iselin NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923786 is the FDA 510(k) clearance record for POLYDOROS XS50 AND SX80, a class I device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K923786.

Clearance record

Decision date
Received
(142 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 186 Wood Ave. S., Iselin NJ
510(k) summary
Summary
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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