The following data is part of a premarket notification filed by Umi, Inc. with the FDA for Grid/radiographic.
| Device ID | K883527 |
| 510k Number | K883527 |
| Device Name: | GRID/RADIOGRAPHIC |
| Classification | Grid, Radiographic |
| Applicant | UMI, INC. 2190 SOUTH MASON RD., SUITE 304 St. Louis, MO 63131 |
| Contact | Maria Bonastia |
| Correspondent | Maria Bonastia UMI, INC. 2190 SOUTH MASON RD., SUITE 304 St. Louis, MO 63131 |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-18 |
| Decision Date | 1988-09-02 |