The following data is part of a premarket notification filed by Diagnostic Imaging Specialists Corp. with the FDA for Rf-1 Circuit.
| Device ID | K871592 |
| 510k Number | K871592 |
| Device Name: | RF-1 CIRCUIT |
| Classification | System, X-ray, Mammographic |
| Applicant | DIAGNOSTIC IMAGING SPECIALISTS CORP. 163 ST. MALO ST. St. Malo, Manitoba, CA R0a1t0 |
| Contact | Gelskey, Phd |
| Correspondent | Gelskey, Phd DIAGNOSTIC IMAGING SPECIALISTS CORP. 163 ST. MALO ST. St. Malo, Manitoba, CA R0a1t0 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-05-22 |