# Imris, Inc.

- Location (FDA's records): Rockville, MD
- FDA decisions: 14 (2006–2015): 14 510(k) clearances
- Product codes: LNH (7), HBL (3), MOS (2), JAK (1), HAW (1)
- Predicates its devices cite: 22 (11 its own); citations of its devices by later devices: 13 (11 its own)
- Recalls linked to its devices: 12 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)
- Pro Med Instruments GmbH: 2 (https://510kreport.com/company/pro-med-instruments)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Medtech S.A.S: 1 (https://510kreport.com/company/medtech)

## Firms that cite its devices most
- Monteris Medical,: 1 (https://510kreport.com/company/monteris-medical)
- Deerfield Imaging, Inc.: 1 (https://510kreport.com/company/deerfield-imaging)

## Its most-cited devices
- K071099: Neuro II-SE, Models: or-DR-or, or-MB (2007), cited by 4
- K083137: Neuro Iii-SV (2008), cited by 3
- K061916: Neuro II-SE, Models or-MB-DR and or-DR (2006), cited by 2
- K103493: Head Fiation Device (HFD 100) (2011), cited by 2
- K091166: IMRX (2009), cited by 1
- K133692: Imri 1.5T and Imri 3T S (2014), cited by 1

## Recent decisions
- K143420: SYMBIS Surgical System (Oct 30, 2015)
- K141950: HFD100 Rocker Arm Accessory (Sep 4, 2014)
- K133692: Imri 1.5T and Imri 3T S (Feb 10, 2014)
- K130224: ICT (Jul 18, 2013)
- K123091: Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T (Dec 27, 2012)
- K121997: Imris Oncology Package (Aug 10, 2012)
- K113748: Imris MR/X-Ray Head Fixation Device (HFD) (Mar 23, 2012)
- K103493: Head Fiation Device (HFD 100) (Mar 11, 2011)

Source page: https://510kreport.com/company/imris