The following data is part of a premarket notification filed by Dilon Technologies, Inc. with the FDA for Dilon 6800 Acella (acella).
| Device ID | K110384 |
| 510k Number | K110384 |
| Device Name: | DILON 6800 ACELLA (ACELLA) |
| Classification | Camera, Scintillation (gamma) |
| Applicant | DILON TECHNOLOGIES, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan DILON TECHNOLOGIES, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-10 |
| Decision Date | 2011-05-03 |
| Summary: | summary |