Noras Mri Products GmbH: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Noras Mri Products GmbH” (first 2008, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 46 days. Since 2017 the median was 64 days, against 58 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 265 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 31 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 179 |
| 2023 | 0 | — |
| 2024 | 1 | 49 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Noras Mri Products GmbH took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 10 | 10 |
Review panels
- Radiology (10)
Most recent Noras Mri Products GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241069 | iLoop Interventional Coil 0.55T | MOS | 2024-06-07 | 49 |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | MOS | 2022-04-08 | 79 |
| 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 | 2022-03-03 | 279 |
| K180123 | Breast BI 7 MR Coil 1.5T Mammavention | MOS | 2018-02-16 | 31 |
| K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | MOS | 2014-08-06 | 265 |
| K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH | MOS | 2010-01-19 | 50 |
| K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | MOS | 2009-06-24 | 28 |
| K083578 | NORAS CPC MULTIFUNCTIONAL COIL | MOS | 2009-01-16 | 44 |
| K082373 | NORAS MR-BI320-PA 3T | MOS | 2008-08-29 | 11 |
| K081118 | NORAS MR-BI320-PA 1.5T | MOS | 2008-05-02 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Noras Mri Products GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Noras Mri Products GmbH (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Noras Rontgen-Und Medizintechnik GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Noras Mri Products GmbH?
FDA lists 10 510(k) clearances under the applicant name “Noras Mri Products GmbH” (first 2008, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Noras Mri Products GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Noras Mri Products GmbH is 46 days. Since 2017: 64 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Noras Mri Products GmbH?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 10).
Next steps
- See all 10 Noras Mri Products GmbH clearances with predicates and recalls
- Run predicate analysis for product code MOS, Noras Mri Products GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.