The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Touch Ultrasound.
| Device ID | K152467 |
| 510k Number | K152467 |
| Device Name: | Touch Ultrasound |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Carolyn L. Wagner |
| Correspondent | Carolyn L. Wagner CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2015-12-09 |
| Summary: | summary |