The following data is part of a premarket notification filed by Nucletron Mfg. Corp. with the FDA for Model Asym-100.
| Device ID | K930213 |
| 510k Number | K930213 |
| Device Name: | MODEL ASYM-100 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | NUCLETRON MFG. CORP. DAVID P. ARMSTRONG BOX 786 Urbana, VA 23175 |
| Contact | Dpa Consulting |
| Correspondent | Dpa Consulting NUCLETRON MFG. CORP. DAVID P. ARMSTRONG BOX 786 Urbana, VA 23175 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-15 |
| Decision Date | 1993-09-07 |