510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882484Substantially Equivalent

Cms Record and Verify System

Elekta Limited, Maryland Heights MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882484 is the FDA 510(k) clearance record for CMS RECORD AND VERIFY SYSTEM, a class II device, cleared for Computerized Medical Systems, Inc. on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list 58 510(k) clearances for ELEKTA LIMITED, from to . As of , FDA records show no recalls naming K882484.

Clearance record

Decision date
Received
(189 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Computerized Medical Systems, Inc. 56 Worthington Dr., Maryland Heights MO
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