The following data is part of a premarket notification filed by Intelligent Instruments Pvt. Ltd. with the FDA for Asha Treatment Planning System, Model Asha Tps.
| Device ID | K002132 |
| 510k Number | K002132 |
| Device Name: | ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | INTELLIGENT INSTRUMENTS PVT. LTD. 202 ASHOK BHAWAN 93 NEHRU PLACE New Delhi, IN |
| Contact | S.l. Kapoor |
| Correspondent | S.l. Kapoor INTELLIGENT INSTRUMENTS PVT. LTD. 202 ASHOK BHAWAN 93 NEHRU PLACE New Delhi, IN |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2001-10-18 |