The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Linac Collimator Assembly Housing (lcah) Model Lcahart.
| Device ID | K100096 |
| 510k Number | K100096 |
| Device Name: | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART |
| Classification | Accelerator, Linear, Medical |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M433LTP1 | K100096 | 000 |
| M248MRCTF21 | K100096 | 000 |