510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110785Substantially Equivalent

Kalare Diagnostic X-Ray Table System

Toshiba Medical Systems Coporation, Japan, Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110785 is the FDA 510(k) clearance record for KALARE DIAGNOSTIC X-RAY TABLE SYSTEM, a class II device, cleared for Toshiba Medical Systems Coporation, Japan on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list 5 510(k) clearances for Toshiba Medical Systems Coporation, Japan, from to . As of , FDA records show one recall naming K110785.

Clearance record

Decision date
Received
(67 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Toshiba Medical Systems Coporation, Japan 2441 Michelle Dr., Tustin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAA

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