ACHIEVA 1.5T & INERA 1.5T FAMILY— 510(k) K052013
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K052013 for ACHIEVA 1.5T & INERA 1.5T FAMILY, Substantially Equivalent on 2005-08-02. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- 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 Nederland B.V.
view all- K254205 — Zenition 30
- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
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 K052013
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-0389-2024 — Achieva 1.5T
- Z-0390-2024 — Achieva 1.5T Conversion
- Z-0392-2024 — Ingenia 1.5T CX
- Z-0393-2024 — Intera 1.5T
- Z-0887-2019 — Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System
- Z-0888-2019 — Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System
- Z-0889-2019 — Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
- Z-0890-2019 — Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
- Z-0891-2019 — Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System
- Z-0892-2019 — Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System
- Z-0894-2019 — Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
- Z-0895-2019 — Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
- Z-0896-2019 — Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
- Z-0899-2019 — Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System
- Z-0908-2019 — Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System
- Z-0909-2019 — Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
- Z-0912-2019 — Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052013.
Data sourced from openFDA. This site is unofficial and independent of the FDA.