DeviceClearance

SmartGuide Disposable Guides and Grids— 510(k) K260161

Substantially Equivalent

UC-CARE , Ltd.

FDA 510(k) clearance K260161 for SmartGuide Disposable Guides and Grids, Substantially Equivalent on 2026-07-30. Applicant: UC-CARE , Ltd.. Device class: 2.

Summary

UC-Care's SmartGuide Disposable Guides and Grids are filed under ITX, diagnostic ultrasonic transducers. The device name describes guides and grids, which the code name doesn't mention, and the record doesn't explain the fit.

Class II, 21 CFR 892.1570. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

UC-Care filed from Yokneam, Israel. Review took 191 calendar days (January 20 to July 30, 2026).

Clearance details

Applicant
UC-CARE , Ltd.
Product code
Product code ITX
Device class
Class 2
Regulation
21 CFR 892.1570
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yokneam, IL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ITX

product code ITX
Death
6
Injury
137
Malfunction
2,036
Total
2,179

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 →

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