Kent Imaging Inc
Calgary Alberta, CA
Kent Imaging Inc appears in FDA device records in Calgary Alberta, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 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 5 510(k) clearances for Kent Imaging Inc between 2012 and 2025. The busiest year on record is 2012, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242669 | SnapshotGLO (KB100) | QJF | Substantially Equivalent | |
| K240601 | SnapshotNIR model KD205 | MUD | Substantially Equivalent | |
| K201976 | SnapshotNIR | MUD | Substantially Equivalent | |
| K163070 | Kent Camera | MUD | Substantially Equivalent | |
| K113507 | KENT CAMERA | MUD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009771004 | 3009771004 | Kent Imaging Inc | Suite 300, 1210 8th Street SW, Calgary Alberta T2R 1L3 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2775-2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected. | Class II | Open, Classified | |
| Z-0789-2024 | Snapshot NIR, REF: KD204 | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain