GE PRECISION MPI
FDA 510(k) clearance K033486 · decided 2003-11-19
Clearance details
- K-number
- K033486
- Device name
- GE PRECISION MPI
- Applicant
- Nrt-Nordisk Rontgen Teknik A/S
- Decision
- Substantially Equivalent
- Date received
- 2003-11-04
- Decision date
- 2003-11-19
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hasselager, DK
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multit recall (Z-0753-2016) | Regulatory Insight, Inc | 2016-02-24 |
| GE Healthcare, Precision MPi fluoroscopic imaging systems. recall (Z-2123-2015) | GE Healthcare | 2015-07-20 |
| GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Pre recall (Z-0911-2014) | GE Healthcare, LLC | 2014-02-03 |
| Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray syst recall (Z-1658-2009) | NRT - Nordisk Rontgen Teknik A/S | 2009-09-29 |
| GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2142-2008) | GE Healthcare | 2008-09-19 |
| GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2143-2008) | GE Healthcare | 2008-09-19 |
| GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2144-2008) | GE Healthcare | 2008-09-19 |