# Mri Interventions, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 14 (2011–2020): 14 510(k) clearances
- Product codes: HAW (4), HBG (3), ORR (2), MOS (1), HBE (1), GWG (1), HCA (1), HBL (1)
- 510(k) review time since 2016: median 30 days, against 138 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 13 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgivision, Inc.: 2 (https://510kreport.com/company/surgivision)
- Surgi-Vision, Inc.: 1 (https://510kreport.com/company/surgi-vision)
- Voyager Therapeutics, Inc.: 1 (https://510kreport.com/company/voyager-therapeutics)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Clinical Neuro Systems, LLC: 1 (https://510kreport.com/company/clinical-neuro-systems)

## Firms that cite its devices most
- Ad-Tech Medical Instrument Corp: 2 (https://510kreport.com/company/ad-tech-medical-instrument)
- ClearPoint Neuro, Inc.: 2 (https://510kreport.com/company/clearpoint-neuro)
- Parker Hannifin Corp.: 1 (https://510kreport.com/company/parker-hannifin)

## Its most-cited devices
- K122456: Mrii Crainial Drill (2013), cited by 4
- K181195: ClearPoint System (2018), cited by 2
- K160129: MRII Cranial Drill and Accessories (2016), cited by 1
- K142505: ClearPoint System (2015), cited by 1
- K160434: ClearPoint System (2016), cited by 1
- K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (2015), cited by 1

## Recent decisions
- K200079: ClearPoint System and Accessories (Feb 13, 2020)
- K191701: Arcus Head Fixation Frame (Nov 15, 2019)
- K191400: Voyager Trajectory Array Guide (V-TAG) (Jun 21, 2019)
- K181731: MR Compatible Aspiration Kit (Nov 20, 2018)
- K181195: ClearPoint System (Nov 2, 2018)
- K171257: ClearPoint System (Oct 20, 2017)
- K160129: MRII Cranial Drill and Accessories (Mar 26, 2016)
- K160434: ClearPoint System (Mar 17, 2016)

Source page: https://510kreport.com/company/mri-interventions