DeviceClearance

K022565

Substantially Equivalent

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915

Applicant
Stereotaxis, Inc.
Product code
JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Saint Louis, MO, US
Download summary PDF View on FDA.gov ↗

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 →

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