MULTIDIAGNOST ELEVA— 510(k) K050151
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K050151 for MULTIDIAGNOST ELEVA, Substantially Equivalent on 2005-02-09. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- 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
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code KPR
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- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K042867 — PHILIPS ORTHOPAEDIC APPLICATIONS
Adverse 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 K050151
K-number listed on FDA's recall record- Z-2411-2026 — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
- Z-3168-2024 — System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva
- Z-2587-2023 — Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
- Z-2404-2023 — MultiDiagnost-Eleva
- Z-1489-2020 — MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
- Z-1055-2019 — MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
- Z-1140-2019 — Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
- Z-1141-2019 — Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
- Z-1603-2018 — MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
- Z-1606-2018 — Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
- Z-1607-2018 — Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
- Z-1608-2018 — MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
- Z-1609-2018 — MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
- Z-1279-2016 — Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography
- Z-1280-2016 — Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0 The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room. FD10 is compatible with specific magnetic navigation systems
- Z-1045-2015 — Philips Multi Diagnost Eleva with FlatDetector
- Z-2156-2012 — Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
- Z-1829-2012 — Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050151.
Data sourced from openFDA. This site is unofficial and independent of the FDA.