The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Konica Srx-101 Automatic X-ray Film Processor.
| Device ID | K931312 |
| 510k Number | K931312 |
| Device Name: | KONICA SRX-101 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 Munves |
| Correspondent | Russell D Munves 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 |