NORAS OR HEAD HOLDER FLEXIBILITY— 510(k) K133506
Substantially EquivalentNoras Mri Products GmbH
FDA 510(k) clearance K133506 for NORAS OR HEAD HOLDER FLEXIBILITY, Substantially Equivalent on 2014-08-06. Applicant: Noras Mri Products GmbH. Device class: 2.
Clearance details
- Applicant
- Noras Mri Products GmbH
- 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
- Hoechberg, DE
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 Noras Mri Products GmbH
view all- K241069 — iLoop Interventional Coil 0.55T
- K220144 — Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
- K211658 — OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
- K180123 — Breast BI 7 MR Coil 1.5T Mammavention
- K093693 — NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
Data sourced from openFDA. This site is unofficial and independent of the FDA.