PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS— 510(k) K082243
Substantially EquivalentGeneral Medical Merate S.P.A
FDA 510(k) clearance K082243 for PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS, Substantially Equivalent on 2008-11-07. Applicant: General Medical Merate S.P.A. Device class: 2.
Clearance details
- Applicant
- General Medical Merate S.P.A
- 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
- Greenwood Village, CO, US
Recent devices under product code OWB
view allMore clearances from General Medical Merate S.P.A
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 K082243
K-number listed on FDA's recall record- Z-2121-2015 — GE Healthcare Precision RXi 23A/32A Analog System
- Z-2122-2015 — GE Healthcare Precision RXi Digital system
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082243.
Data sourced from openFDA. This site is unofficial and independent of the FDA.