HHF1 MAGNETIC RESONANCE IMAGING SYSTEM— 510(k) K052172
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K052172 for HHF1 MAGNETIC RESONANCE IMAGING SYSTEM, Substantially Equivalent on 2005-09-27. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Systems America, 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
- Abbreviated
- Location
- Twinsburg, OH, US
Recent devices under product code LNH
view allMore clearances from Hitachi Medical Systems America, 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 K052172
K-number listed on FDA's recall record- Z-1559-2013 — Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
- Z-2254-2012 — Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052172.
Data sourced from openFDA. This site is unofficial and independent of the FDA.