DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
FDA 510(k) clearance K060259 · decided 2006-02-22
Clearance details
- K-number
- K060259
- Device name
- DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-02-01
- Decision date
- 2006-02-22
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: recall (Z-2376-2012) | GE Healthcare, LLC | 2012-09-13 |
| GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated fo recall (Z-0540-2010) | GE Medical Systems, LLC | 2009-12-16 |
| Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. recall (Z-0138-2010) | GE Medical Systems, LLC | 2009-11-09 |
| Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems a recall (Z-1195-2009) | GE Medical Systems, LLC | 2009-05-19 |