INTERA I/T— 510(k) K013344
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K013344 for INTERA I/T, Substantially Equivalent on 2001-12-11. 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
- Milford, CT, 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 K013344
K-number listed on FDA's recall record- Z-0885-2019 — Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System
- 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 K013344.
Data sourced from openFDA. This site is unofficial and independent of the FDA.