DISCOVERY IGS 740
FDA 510(k) clearance K133278 · decided 2014-04-24
Clearance details
- K-number
- K133278
- Device name
- DISCOVERY IGS 740
- Applicant
- GE Medical Systems SCS
- Decision
- Substantially Equivalent
- Date received
- 2013-10-24
- Decision date
- 2014-04-24
- Days to decision
- 182 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 |
|---|---|---|
| Discovery IGS 740 Interventional Fluoroscopic X-ray Systems recall (Z-2388-2018) | GE Medical Systems, SCS | 2018-10-05 |
| GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotatio recall (Z-1707-2016) | GE Medical Systems, LLC | 2016-05-23 |
| GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems recall (Z-1975-2015) | GE Healthcare | 2015-07-03 |
| GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic recall (Z-0966-2015) | GE Healthcare | 2015-01-14 |
| Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating f recall (Z-0452-2015) | GE Healthcare, LLC | 2014-12-16 |