The following data is part of a premarket notification filed by Diagnosoft, Inc. with the FDA for Diagnosoft Harp Model 2.06.
| Device ID | K100352 |
| 510k Number | K100352 |
| Device Name: | DIAGNOSOFT HARP MODEL 2.06 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Jeffrey Roberts |
| Correspondent | Jeffrey Roberts DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-03-11 |
| Summary: | summary |