FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
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
K Number: K211658
·
Decision Mar 3, 2022
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
10
Review Days
279
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Basic Information
- Device Name
- 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
- K Number
- K211658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Noras Mri Products GmbH
- Date Received
- May 28, 2021
- Decision Date
- March 3, 2022
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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Other Clearances by Noras Mri Products GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K241069 | iLoop Interventional Coil 0.55T | Jun 7, 2024 | Substantially Equivalent |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | Apr 8, 2022 | Substantially Equivalent |
| K180123 | Breast BI 7 MR Coil 1.5T Mammavention | Feb 16, 2018 | Substantially Equivalent |
| K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | Aug 6, 2014 | Substantially Equivalent |
| K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH | Jan 19, 2010 | Substantially Equivalent |
| K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | Jun 24, 2009 | Substantially Equivalent |
| K083578 | NORAS CPC MULTIFUNCTIONAL COIL | Jan 16, 2009 | Substantially Equivalent |
| K082373 | NORAS MR-BI320-PA 3T | Aug 29, 2008 | Substantially Equivalent |
| K081118 | NORAS MR-BI320-PA 1.5T | May 2, 2008 | Substantially Equivalent |