The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Operating Arm System (oas).
| Device ID | K951262 |
| 510k Number | K951262 |
| Device Name: | OPERATING ARM SYSTEM (OAS) |
| Classification | System, Image Processing, Radiological |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-11-13 |