The following data is part of a premarket notification filed by Advanced Image Science, Inc. with the FDA for Provu (tm) Dental X-ray System.
| Device ID | K102573 |
| 510k Number | K102573 |
| Device Name: | PROVU (TM) DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Intraoral |
| Applicant | ADVANCED IMAGE SCIENCE, INC. 1999 SOUTH BASOM AVENUE, SUITE 700 Campbell, CA 95008 |
| Contact | Paul Rockwell |
| Correspondent | Paul Rockwell ADVANCED IMAGE SCIENCE, INC. 1999 SOUTH BASOM AVENUE, SUITE 700 Campbell, CA 95008 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-06-30 |