RADSPA— 510(k) K141329
Substantially EquivalentTelerad 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
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.