PHILLIPS OMNIDIAGNOST ELEVA— 510(k) K032046
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K032046 for PHILLIPS OMNIDIAGNOST ELEVA, Substantially Equivalent on 2003-07-17. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- 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
- Da Best, NL
Recent devices under product code OWB
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view all- K093355 — PCR ELEVA 1.2
- K090808 — PINNACLE3 SMARTARC
- K071391 — PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- K063783 — PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
- K041741 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
Adverse 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 K032046
K-number listed on FDA's recall record- Z-1490-2020 — OmniDiagnost Eleva System codes 708028 708027
- Z-1056-2019 — URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
- Z-2300-2018 — OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032046.
Data sourced from openFDA. This site is unofficial and independent of the FDA.