510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K855063Substantially Equivalent

Universal Patient Chair Uni 2000X

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

K855063 is the FDA 510(k) clearance record for UNIVERSAL PATIENT CHAIR UNI 2000X, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code JAI (Couch, Radiation Therapy, Powered). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K855063.

Clearance record

Decision date
Received
(43 days to decision)
Product code
JAI Couch, Radiation Therapy, Powered
Regulation
21 CFR 892.5770
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 JAI

Trailing 12 months

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

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