The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Ultrasonic Imaging System (modified).
| Device ID | K860568 |
| 510k Number | K860568 |
| Device Name: | ULTRASONIC IMAGING SYSTEM (MODIFIED) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Bernardi Phd |
| Correspondent | Bernardi Phd INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-08-11 |