RADSPA— 510(k) K141329

Substantially Equivalent

Telerad Tech Private Limited

FDA 510(k) clearance K141329 for RADSPA, Substantially Equivalent on 2014-06-20. Applicant: Telerad Tech Private Limited.

Clearance details

Applicant
Telerad Tech Private Limited
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Aurora, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.