ILAB ULTRASOUND IMAGING SYSTEM
FDA 510(k) clearance K051679 · decided 2005-07-14
Clearance details
- K-number
- K051679
- Device name
- ILAB ULTRASOUND IMAGING SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-06-23
- Decision date
- 2005-07-14
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Numbe recall (Z-0395-2007) | Boston Scientific Target | 2007-02-01 |
| iLab Utrasound Imaging System, software controlled Imaging Catheter. recall (Z-0789-06) | Boston Scientific Target | 2006-04-22 |