The following data is part of a premarket notification filed by C.l. Mcintosh & Assoc., Inc. with the FDA for Autimo 2.5-d And Autimo 3-d.
| Device ID | K972016 |
| 510k Number | K972016 |
| Device Name: | AUTIMO 2.5-D AND AUTIMO 3-D |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-12-04 |
| Summary: | summary |