PHILIPS EASYDIAGNOST ELEVA— 510(k) K031535
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K031535 for PHILIPS EASYDIAGNOST ELEVA, Substantially Equivalent on 2003-06-17. Applicant: Philips Medical Systems North America Co.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
Recent devices under product code KPR
view allMore clearances from Philips Medical Systems North America Co.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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 K031535
K-number listed on FDA's recall record- Z-0279-2024 — EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
- Z-2523-2020 — EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
- Z-0311-2018 — Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
- Z-0365-2016 — Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
- Z-0431-2014 — Easy Diagnost Eleva Universal Fluoroscopic applications
- Z-0767-2013 — Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
- Z-2208-2012 — Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
- Z-1821-2012 — Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.