FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K Number: K022565
·
Decision Oct 8, 2002
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
28
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
- K Number
- K022565
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stereotaxis, Inc.
- Date Received
- August 2, 2002
- Decision Date
- October 8, 2002
- Product Code
- JAA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Nexus DRF Digital X-ray Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Insight Enhanced DRF (EN-1002-01)
FDA 510(k)
FDA Class 2
·Radiology
Soteria E-View
FDA 510(k)
FDA Class 2
·Radiology
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Stereotaxis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253473 | Synchrony | Apr 1, 2026 | Substantially Equivalent |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Nov 6, 2025 | Substantially Equivalent |
| K250590 | MAGiC Sweep EP Mapping Catheter | Jul 23, 2025 | Substantially Equivalent |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Mar 5, 2020 | Substantially Equivalent |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Oct 30, 2019 | Substantially Equivalent |
| K183027 | Steerable catheter control system | Sep 6, 2019 | Substantially Equivalent |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Jun 17, 2015 | Substantially Equivalent |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Dec 18, 2014 | Substantially Equivalent |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Sep 3, 2014 | Substantially Equivalent |
| K133396 | VDRIVE WITH V-SONO | Feb 6, 2014 | Substantially Equivalent |