NORAS MRI products GmbH
HOECHBERG Bavaria, DE
NORAS MRI products GMBH appears in FDA device records in HOECHBERG Bavaria, DE. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for NORAS MRI products GmbH between 2008 and 2024. The busiest year on record is 2008, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241069 | iLoop Interventional Coil 0.55T | MOS | Substantially Equivalent | |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | MOS | Substantially Equivalent | |
| 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 | MOS | Substantially Equivalent | |
| K180123 | Breast BI 7 MR Coil 1.5T Mammavention | MOS | Substantially Equivalent | |
| K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | MOS | Substantially Equivalent | |
| K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH | MOS | Substantially Equivalent | |
| K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | MOS | Substantially Equivalent | |
| K083578 | NORAS CPC MULTIFUNCTIONAL COIL | MOS | Substantially Equivalent | |
| K082373 | NORAS MR-BI320-PA 3T | MOS | Substantially Equivalent | |
| K081118 | NORAS MR-BI320-PA 1.5T | MOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004929307 | 3004929307 | NORAS MRI products GMBH | LEIBNIZSTRASSE 4, HOECHBERG Bavaria 97204 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain