INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100— 510(k) K003853
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K003853 for INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100, Substantially Equivalent on 2001-02-13. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), 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
- Cleveland, OH, US
Recent devices under product code LNH
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
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 K003853
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003853.
Data sourced from openFDA. This site is unofficial and independent of the FDA.