510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K874214Substantially Equivalent

S9 Display System

O.M.I. Oncology Microsystems, Inc., Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874214 is the FDA 510(k) clearance record for S9 DISPLAY SYSTEM, a class II device, cleared for O.M.I. Oncology Microsystems, Inc. on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list 2 510(k) clearances for O.M.I. Oncology Microsystems, Inc., from to . As of , FDA records show no recalls naming K874214.

Clearance record

Decision date
Received
(129 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
O.M.I. Oncology Microsystems, Inc. 2232 Tashy Pl., Canada, CA
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260