The following data is part of a premarket notification filed by Arizona State Radiology with the FDA for Pc Teleradiology(tm).
Device ID | K925050 |
510k Number | K925050 |
Device Name: | PC TELERADIOLOGY(TM) |
Classification | System, Digital Image Communications, Radiological |
Applicant | ARIZONA STATE RADIOLOGY 1845 WEST ORANGE GROVE RD. BUILDING #3 Tucson, AZ 85704 |
Contact | Phillip Berman |
Correspondent | Phillip Berman ARIZONA STATE RADIOLOGY 1845 WEST ORANGE GROVE RD. BUILDING #3 Tucson, AZ 85704 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-06 |
Decision Date | 1993-05-03 |