The following data is part of a premarket notification filed by Diagnosoft, Inc. with the FDA for Diagnosoft Harp.
| Device ID | K061368 |
| 510k Number | K061368 |
| Device Name: | DIAGNOSOFT HARP |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | DIAGNOSOFT, INC. 3461 KENNETH DRIVE Palo Alto, CA 94303 |
| Contact | Amr A Awadallah |
| Correspondent | Amr A Awadallah DIAGNOSOFT, INC. 3461 KENNETH DRIVE Palo Alto, CA 94303 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-07-28 |
| Summary: | summary |