The following data is part of a premarket notification filed by Envisioneering, Llc. with the FDA for Targetscan Transrectal Ultrasound System.
| Device ID | K041637 |
| 510k Number | K041637 |
| Device Name: | TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis, MO 63114 |
| Contact | Tom Kappel |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-17 |
| Decision Date | 2004-09-01 |
| Summary: | summary |