The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Touch Ultrasound.
| Device ID | K150342 |
| 510k Number | K150342 |
| Device Name: | Touch Ultrasound |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978607006 | K150342 | 000 |
| 60889971734594 | K150342 | 000 |
| 60889971734587 | K150342 | 000 |
| 60889971734556 | K150342 | 000 |
| 60889971734549 | K150342 | 000 |
| 60889971734532 | K150342 | 000 |
| 60889971734525 | K150342 | 000 |
| 60889971734518 | K150342 | 000 |
| 60889971734501 | K150342 | 000 |
| 60889971734600 | K150342 | 000 |
| 60889971734617 | K150342 | 000 |
| 60889971734624 | K150342 | 000 |
| 60889971750525 | K150342 | 000 |
| 60889971750518 | K150342 | 000 |
| 60889971750501 | K150342 | 000 |
| 60889971750495 | K150342 | 000 |
| 60889971750488 | K150342 | 000 |
| 60889971738837 | K150342 | 000 |
| 60889971738820 | K150342 | 000 |
| 60889971734631 | K150342 | 000 |
| 60889971734495 | K150342 | 000 |