Medical Device Manufacturer · US , Hudson , NH

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

5 submissions · 5 cleared · Since 1996

Recent clearances: DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0), DIGITIZER DIRECTOR (HSC025-01), HOWTEK 960

5

Total

5

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Aug 12, 2002

Radiology · 60d

Cleared Nov 05, 1997

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)

Radiology · 79d

Cleared Sep 08, 1997

DIGITIZER DIRECTOR (HSC025-01)

Radiology · 90d

Cleared May 20, 1997

Radiology · 70d

Cleared Jan 18, 1996

Radiology · 199d