The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Patient Information Manager (pim).
| Device ID | K921986 |
| 510k Number | K921986 |
| Device Name: | PATIENT INFORMATION MANAGER (PIM) |
| Classification | System, X-ray, Mammographic |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Oscar Khutoryansky |
| Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1992-10-16 |