Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
FDA 510(k) clearance K181403 · decided 2018-11-02
Clearance details
- K-number
- K181403
- Device name
- Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2018-05-29
- Decision date
- 2018-11-02
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buc, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Innova IGS 5, computed tomography x-ray system recall (Z-1777-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems recall (Z-1778-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems recall (Z-1782-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems recall (Z-1783-2024) | GE Medical Systems, SCS | 2024-05-06 |
| GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Inno recall (Z-1864-2021) | GE Healthcare, LLC | 2021-06-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| 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 |