The following data is part of a premarket notification filed by Telerad Tech Private Limited with the FDA for Radspa.
| Device ID | K141329 |
| 510k Number | K141329 |
| Device Name: | RADSPA |
| Classification | System, Image Processing, Radiological |
| Applicant | TELERAD TECH PRIVATE LIMITED 2871 COASTAL DR. Aurora, IL 60503 |
| Contact | Manoj Zacharias |
| Correspondent | Manoj Zacharias TELERAD TECH PRIVATE LIMITED 2871 COASTAL DR. Aurora, IL 60503 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-06-20 |
| Summary: | summary |