510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910002Substantially Equivalent

Genesys and the Roi

The Complete Systems Corp. Genesys, Maitland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910002 is the FDA 510(k) clearance record for GENESYS AND THE ROI, a class II device, cleared for The Complete Systems Corp. Genesys on under FDA product code JAI (Couch, Radiation Therapy, Powered). FDA records list one 510(k) clearance for The Complete Systems Corp. Genesys. As of , FDA records show no recalls naming K910002.

Clearance record

Decision date
Received
(201 days to decision)
Product code
JAI Couch, Radiation Therapy, Powered
Regulation
21 CFR 892.5770
Device class
Class II
Review panel
Radiology
Applicant
The Complete Systems Corp. Genesys 2301 Lucien Way, Maitland FL
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