Digital Pathology Image Artifact Detection Software Device
Regulation 864.3700
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SIX
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Biosystems Imaging, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K253561 | Aperio iQC DX Software Leica Biosystems Imaging, Inc. | SIX |
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