510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040804Substantially Equivalent

.Decimal Tissue Compensator/intensity Modulator

Southeastern Radiation Products, Inc., Sanford FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040804 is the FDA 510(k) clearance record for .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR, a class II device, cleared for Southeastern Radiation Products, Inc. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 2 510(k) clearances for Southeastern Radiation Products, Inc., from to . As of , FDA records show no recalls naming K040804.

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
Southeastern Radiation Products, Inc. 2651 N. Design Ct., Sanford FL
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