NOT

FDA Product Code NOT:

Leading manufacturers include Ventana Medical Systems, Inc..

13
Total
13
Cleared
214d
Avg days
2003
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 115d recently vs 222d historically

FDA 510(k) Cleared NOT Devices (Product Code NOT)

13 devices
1–13 of 13
Cleared Sep 06, 2013
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033
Ventana Medical Systems, Inc.
Pathology · 519d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350
Ventana Medical Systems, Inc.
Pathology · 28d
Cleared Feb 22, 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755
Ventana Medical Systems, Inc.
Pathology · 245d
Cleared Oct 12, 2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543
Ventana Medical Systems, Inc.
Pathology · 132d

About Product Code NOT - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code NOT since 2003, with 13 receiving FDA clearance (average review time: 214 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NOT Product Code

Recent submissions under NOT have taken an average of 115 days to reach a decision - down from 222 days historically, suggesting improved FDA processing for this classification.

NOT devices are reviewed by the Pathology panel. Browse all Pathology devices →