# ORR: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 1
- 2017: 1
- 2018: 1

## Most-cited predicates
- K181195: ClearPoint System (2018), cited by 2
- K111073: Surgivision Inc. Clearpoint System (2011), cited by 1
- K100836: Clearpoint System (2010), cited by 1
- K171257: ClearPoint System (2017), cited by 1

Source page: https://510kreport.com/product-code/ORR
Data by year (CSV): https://510kreport.com/product-code/ORR.csv