The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for I-cat Scanner.
| Device ID | K061284 |
| 510k Number | K061284 |
| Device Name: | I-CAT SCANNER |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Contact | David W Cowan |
| Correspondent | David W Cowan IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV083090000 | K061284 | 000 |
| EKAV083080000 | K061284 | 000 |
| EKAV083070000 | K061284 | 000 |
| EKAV083050000 | K061284 | 000 |
| EKAV083040000 | K061284 | 000 |
| EKAV083030000 | K061284 | 000 |
| EKAV083020000 | K061284 | 000 |
| EKAV083010000 | K061284 | 000 |
| EKAV083000000 | K061284 | 000 |