The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Lcm-2-linac Couch-mount System.
| Device ID | K924632 |
| 510k Number | K924632 |
| Device Name: | LCM-2-LINAC COUCH-MOUNT SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-14 |
| Decision Date | 1993-04-07 |