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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Noras Mri Products GmbH · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time
279 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH2024-06-07490
K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; BreaNoras Mri Products GmbH2022-04-08790
K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head HNoras Mri Products GmbH2022-03-032790
K180123Breast BI 7 MR Coil 1.5T MammaventionNoras Mri Products GmbH2018-02-16310
K133506NORAS OR HEAD HOLDER FLEXIBILITYNoras Mri Products GmbH2014-08-062650
K093693NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PNoras Mri Products GmbH2010-01-19500
K091546NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH2009-06-24280
K083578NORAS CPC MULTIFUNCTIONAL COILNoras Mri Products GmbH2009-01-16440
K082373NORAS MR-BI320-PA 3TNoras Mri Products GmbH2008-08-29110
K081118NORAS MR-BI320-PA 1.5TNoras Mri Products GmbH2008-05-02110

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda