Medical Device Manufacturer · US , Jacksonville , FL

Viztek, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2001

Recent clearances: VIZION DR, VIZTEK WL, VIZTEK DR, MODELS: DR1000, DR3000, DR4000

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Viztek, Inc. Radiology ✕

5 devices

1-5 of 5

Cleared Jan 24, 2011

Radiology · 179d

Cleared Nov 12, 2009

Radiology · 149d

Cleared Nov 21, 2008

VIZTEK DR, MODELS: DR1000, DR3000, DR4000

Radiology · 74d

Cleared Dec 12, 2006

Radiology · 36d

Cleared Feb 15, 2001

ONYX-RAD TELEMEDICINE PACS

Radiology · 85d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 28, 2026