The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for 2000 X-ray - Tomographic.
| Device ID | K931815 |
| 510k Number | K931815 |
| Device Name: | 2000 X-RAY - TOMOGRAPHIC |
| Classification | System, X-ray, Tomographic |
| Applicant | IMAGING SCIENCES INTL., INC. 1308 MEETINGHOUSE RD. P.O. BOX 73 Gwynedd, PA 19436 |
| Contact | Edward J Marandola |
| Correspondent | Edward J Marandola IMAGING SCIENCES INTL., INC. 1308 MEETINGHOUSE RD. P.O. BOX 73 Gwynedd, PA 19436 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1993-08-23 |