Exact Imaging, Inc.
Markham Ontario, CA
EXACT IMAGING, INC. appears in FDA device records in Markham Ontario, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Exact Imaging, Inc. between 2016 and 2019. The busiest year on record is 2019, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192303 | ExactVu High Resolution Micro-Ultrasound System | IYN | Substantially Equivalent | |
| K190995 | ExactVu High Resolution Micro-Ultrasound System | IYN | Substantially Equivalent | |
| K180636 | ExactVu High Resolution Micro-Ultrasound System | IYO | Substantially Equivalent | |
| K162972 | ExactVu High Resolution Micro-Ultrasound System | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012402886 | 3012402886 | EXACT IMAGING, INC. | 7676 Woodbine Avenue, Markham Ontario L3R 2N2 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain