# Aurora Imaging Technology, Inc.

- Location (FDA's records): North Andover, MA
- FDA decisions: 7 (2001–2008): 7 510(k) clearances
- Product codes: LNH (7)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 4 (4 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
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K032082: Aurora (2003), cited by 3
- K012154: Aurora Magnetic Resonance Diagnostic Device (2001), cited by 1

## Recent decisions
- K073425: Modification to Aurora Mri System (Sep 16, 2008)
- K052698: Modification to: Aurora (Nov 8, 2005)
- K032678: Modification to: Aurora (Sep 24, 2003)
- K032082: Aurora (Jul 30, 2003)
- K023686: Aurora MR-Guided Interventional System (Jan 29, 2003)
- K012154: Aurora Magnetic Resonance Diagnostic Device (Sep 19, 2001)
- K003651: Aurora (Feb 21, 2001)

Source page: https://510kreport.com/company/aurora-imaging-technology