The following data is part of a premarket notification filed by Picofemto Llc with the FDA for Cliniscansm Mri.
| Device ID | K153593 |
| 510k Number | K153593 |
| Device Name: | CliniscanSM MRI |
| Classification | System, Image Processing, Radiological |
| Applicant | PICOFEMTO LLC 228 EAST 45TH STREET New York, NY 10017 |
| Contact | Jessica Phillips |
| Correspondent | Jessica Phillips PICOFEMTO LLC 228 EAST 45TH STREET New York, NY 10017 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-02-17 |