510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043336Substantially Equivalent

Optistrand, Model 1032S

Ibt SA, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043336 is the FDA 510(k) clearance record for OPTISTRAND, MODEL 1032S, a class II device, cleared for Ibt SA on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 3 510(k) clearances for Ibt SA, from to . As of , FDA records show no recalls naming K043336.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Ibt SA 6000 Live Oak Pkwy., Suite 107, Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK 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 KXK, 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