The following data is part of a premarket notification filed by Merlin Engineering Works, Inc. with the FDA for Upscan.
| Device ID | K933512 |
| 510k Number | K933512 |
| Device Name: | UPSCAN |
| Classification | System, X-ray, Stationary |
| Applicant | MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303 |
| Contact | Robert Van Waldelen |
| Correspondent | Robert Van Waldelen MERLIN ENGINEERING WORKS, INC. 1888 EMBARCADERO RD. Palo Alto, CA 94303 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1995-04-19 |