510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040553Substantially Equivalent

Modification to Acculeaf

Direx Systems Corp., Natick MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040553 is the FDA 510(k) clearance record for MODIFICATION TO ACCULEAF, a class II device, cleared for Direx Systems Corp. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 22 510(k) clearances for Direx Systems Corp., from to . As of , FDA records show no recalls naming K040553.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Direx Systems Corp. 11 Mercer Rd., Natick MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IXI

Trailing 12 months
1 clearance under product code IXI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260