GE PRECISION MPI— 510(k) K033486
Substantially EquivalentNrt-Nordisk Rontgen Teknik A/S
FDA 510(k) clearance K033486 for GE PRECISION MPI, Substantially Equivalent on 2003-11-19. Applicant: Nrt-Nordisk Rontgen Teknik A/S. Device class: 2.
Clearance details
- Applicant
- Nrt-Nordisk Rontgen Teknik A/S
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasselager, DK
Recent devices under product code OWB
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K033486
K-number listed on FDA's recall record- Z-2123-2015 — GE Healthcare, Precision MPi fluoroscopic imaging systems.
- Z-0911-2014 — GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- Z-0753-2016 — GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033486.
Data sourced from openFDA. This site is unofficial and independent of the FDA.