The following data is part of a premarket notification filed by Scimage, Inc. with the FDA for Scimage Picomenterprise.
| Device ID | K073169 |
| 510k Number | K073169 |
| Device Name: | SCIMAGE PICOMENTERPRISE |
| Classification | System, Image Processing, Radiological |
| Applicant | SCIMAGE, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook SCIMAGE, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-09 |
| Decision Date | 2008-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861917000305 | K073169 | 000 |
| 60889971001894 | K073169 | 000 |