The following data is part of a premarket notification filed by Howtek, Inc. with the FDA for Digitizer Director: Image Compression Module (ho4059-rev 2.0).
| Device ID | K973081 |
| 510k Number | K973081 |
| Device Name: | DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) |
| Classification | System, Image Processing, Radiological |
| Applicant | HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Contact | Russell Leonard |
| Correspondent | Russell Leonard HOWTEK, INC. 21 PARK AVE. Hudson, NH 03051 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-05 |
| Summary: | summary |