The following data is part of a premarket notification filed by All-pro Imaging Corp. with the FDA for Aii-pro 100 Plus And All-pro 200.
| Device ID | K991435 |
| 510k Number | K991435 |
| Device Name: | AII-PRO 100 PLUS AND ALL-PRO 200 |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801 |
| Contact | Frederick R Fischer |
| Correspondent | Frederick R Fischer ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-20 |