ACHIEVA FAMILY— 510(k) K043147
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K043147 for ACHIEVA FAMILY, Substantially Equivalent on 2005-02-15. 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 K043147
K-number listed on FDA's recall record- Z-2163-2024 — SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
- Z-2164-2024 — SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
- Z-2165-2024 — SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
- Z-0884-2019 — Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
- Z-0893-2019 — Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System
- Z-0897-2019 — Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System
- Z-0905-2019 — Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
- Z-0906-2019 — Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System
- Z-0907-2019 — Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
- Z-0913-2019 — Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System
- Z-0914-2019 — Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
- Z-0927-2019 — Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
- Z-0928-2019 — Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043147.
Data sourced from openFDA. This site is unofficial and independent of the FDA.