The following data is part of a premarket notification filed by Inteleradiology, Inc. with the FDA for Itr2000: Internet Teleradiology, Model Release 1.0.
| Device ID | K992352 |
| 510k Number | K992352 |
| Device Name: | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | INTELERADIOLOGY, INC. 2400 LORAIN RD. San Marino, CA 91108 |
| Contact | Michael Vincent Klein |
| Correspondent | Michael Vincent Klein INTELERADIOLOGY, INC. 2400 LORAIN RD. San Marino, CA 91108 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-14 |
| Decision Date | 1999-09-29 |
| Summary: | summary |