The following data is part of a premarket notification filed by Life Instrument Corp. with the FDA for Ultrasound Breast Scanning Device.
| Device ID | K781177 |
| 510k Number | K781177 |
| Device Name: | ULTRASOUND BREAST SCANNING DEVICE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | LIFE INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-06 |
| Decision Date | 1979-01-03 |