GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
FDA 510(k) clearance K092004 · decided 2009-08-25
Clearance details
- K-number
- K092004
- Device name
- GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2009-07-02
- Decision date
- 2009-08-25
- Days to decision
- 54 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 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imagin recall (Z-0934-2013) | GE Healthcare, LLC | 2013-03-11 |
| GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicate recall (Z-0133-2012) | GE Healthcare, LLC | 2011-10-28 |
PMA approvals by this applicant
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|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
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| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |