DeviceClearance

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM— 510(k) K110785

Substantially Equivalent

Toshiba Medical Systems Coporation, Japan

FDA 510(k) clearance K110785 for KALARE DIAGNOSTIC X-RAY TABLE SYSTEM, Substantially Equivalent on 2011-05-27. Applicant: Toshiba Medical Systems Coporation, Japan. Device class: 2.

Clearance details

Applicant
Toshiba Medical Systems Coporation, Japan
Product code
Code JAA
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tustin, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JAA

product code JAA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K110785

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110785.

Data sourced from openFDA. This site is unofficial and independent of the FDA.