The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Konica Qx-70 Automatic X-ray Film Processor.
Device ID | K931314 |
510k Number | K931314 |
Device Name: | KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | KONICA MEDICAL CORP. C/O STORCH AMINI & MUNVES, P.C 1090 VERMONT AVE NW, STE 800 Washington, DC 20005 |
Contact | Russell D Mlunves |
Correspondent | Russell D Mlunves KONICA MEDICAL CORP. C/O STORCH AMINI & MUNVES, P.C 1090 VERMONT AVE NW, STE 800 Washington, DC 20005 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-15 |
Decision Date | 1993-09-07 |