INTERA FAMILY— 510(k) K030520
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K030520 for INTERA FAMILY, Substantially Equivalent on 2003-03-06. Applicant: Philips Medical Systems North America Co.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- 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
view allMore clearances from Philips Medical Systems North America Co.
view allAdverse 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 K030520
K-number listed on FDA's recall record- Z-0874-2019 — Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System
- Z-0877-2019 — Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System
- Z-0878-2019 — Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System
- Z-0879-2019 — Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System
- Z-0880-2019 — Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System
- Z-0881-2019 — Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System
- Z-0883-2019 — Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System
- Z-0886-2019 — Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
- Z-1431-2018 — Intera 0.5T Standard, Model 781101 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.
- Z-1432-2018 — Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 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.
- Z-1024-2016 — SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030520.
Data sourced from openFDA. This site is unofficial and independent of the FDA.