GEM OPTION FOR 1.5 MRI SYSTEMS— 510(k) K103335
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K103335 for GEM OPTION FOR 1.5 MRI SYSTEMS, Substantially Equivalent on 2011-03-07. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aurora, OH, US
Recent devices under product code MOS
view all- 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
- K260947 — 0.55T 12Ch Breast Coil
- K252587 — HD 8Ch Wrist Array
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
More clearances from GE Healthcare
view allRecalls naming K103335
K-number listed on FDA's recall record- Z-1533-2014 — GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
- Z-1480-2014 — GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103335.
Data sourced from openFDA. This site is unofficial and independent of the FDA.