# Exact Imaging, Inc.

- Location (FDA's records): Markham, CA
- FDA decisions: 4 (2016–2019): 4 510(k) clearances
- Names in FDA's records: Exact Imaging, Inc. (3); Exact Imaging (1)
- Product codes: IYO (2), IYN (2)
- 510(k) review time since 2016: median 39 days, against 68 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 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
- B-K Medical Aps: 1 (https://510kreport.com/company/b-k-medical)

## Its most-cited devices
- K180636: ExactVu High Resolution Micro-Ultrasound System (2018), cited by 1
- K190995: ExactVu High Resolution Micro-Ultrasound System (2019), cited by 1
- K162972: ExactVu High Resolution Micro-Ultrasound System (2016), cited by 1

## Recent decisions
- K192303: ExactVu High Resolution Micro-Ultrasound System (Oct 1, 2019)
- K190995: ExactVu High Resolution Micro-Ultrasound System (May 10, 2019)
- K180636: ExactVu High Resolution Micro-Ultrasound System (Apr 30, 2018)
- K162972: ExactVu High Resolution Micro-Ultrasound System (Dec 2, 2016)

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