PANORAMA 1.0T— 510(k) K041602
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K041602 for PANORAMA 1.0T, Substantially Equivalent on 2004-07-26. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code LNH
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view all- K102005 — ALLURA XPER OR TABLE SERIES
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K061052 — THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
- K050151 — MULTIDIAGNOST ELEVA
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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 K041602
K-number listed on FDA's recall record- Z-0505-2024 — Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
- Z-0898-2019 — Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System
- Z-0917-2019 — Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
- Z-1434-2018 — Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041602.
Data sourced from openFDA. This site is unofficial and independent of the FDA.