The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for Panatome.
| Device ID | K991518 |
| 510k Number | K991518 |
| Device Name: | PANATOME |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Contact | Robert E Hay |
| Correspondent | Robert E Hay IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-30 |
| Decision Date | 1999-06-18 |
| Summary: | summary |