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Pathology devices

83 product codes reviewed by the Pathology panel. 344 510(k) clearances and 257 recalls in the FDA data, 4% of those recalls name a 510(k).

12510(k)s in 12 months

23recalls in 12 months

10recalls that name a 510(k)

Active product codes, Class II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
PSY	Whole Slide Imaging System	2	4	1
QKQ	Digital Pathology Image Viewing And Management Software	2	3	0
SHW	Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis	2	2	0
PZM	Next Generation Sequencing Based Tumor Profiling Test	2	1	0
QDS	Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System	2	0	1
QYV	Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm	2	0	1
SBY	High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids	2	1	0
SIX	Digital Pathology Image Artifact Detection Software Device	2	1	0