Total clearances
3
2020-11-10 → 2025-03-26
Name variants in FDA filings: Kent Imaging / Kent Imaging, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| MUD |
— |
— |
— |
2 |
2024-04-02 |
| QJF |
— |
— |
— |
1 |
2025-03-26 |
Safety
Recalls (2)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2026-06-30 |
Class II
|
Ongoing |
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 … |
| 2023-10-30 |
Class II
|
Ongoing |
Z-0789-2024 |
Snapshot NIR, REF: KD204 |
— |
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-03-26 |
K242669 |
SnapshotGLO (KB100) |
QJF |
— |
— |
| 2024-04-02 |
K240601 |
SnapshotNIR model KD205 |
MUD |
— |
— |
| 2020-11-10 |
K201976 |
SnapshotNIR |
MUD |
— |
— |