510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911082Substantially Equivalent

Real Time X-Ray Imaging System

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

K911082 is the FDA 510(k) clearance record for REAL TIME X-RAY IMAGING SYSTEM, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K911082.

Clearance record

Decision date
Received
(51 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 186 Wood Ave. S., Iselin NJ
Third party review
No

Clearances, product code LMA

Trailing 12 months

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

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