510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130443Substantially Equivalent

I-Max Touch 3D

Owandy Inc., Ormond Beach FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130443 is the FDA 510(k) clearance record for I-MAX TOUCH 3D, a class II device, cleared for Owandy on under FDA product code OAS (X-Ray, Tomography, Computed, Dental). FDA's definition for product code OAS reads: "Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth". FDA records list 6 510(k) clearances for Owandy, from to . As of , FDA records show one recall naming K130443.

Clearance record

Decision date
Received
(113 days to decision)
Product code
OAS X-Ray, Tomography, Computed, Dental
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Owandy 110 E. Granada Blvd., Suite 207, Ormond Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAS

Trailing 12 months
10 clearances under product code OAS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OAS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20261
March 20262
April 20261
May 20261
June 20262
July 20261
August 20260
September 20260
October 20260