The following data is part of a premarket notification filed by Aspect Imaging Ltd. with the FDA for Embrace Neonatal Mri System.
| Device ID | K170978 |
| 510k Number | K170978 |
| Device Name: | Embrace Neonatal MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Aspect Imaging Ltd. 27 Shaked St. Industrial Area Hevel Modi’in., IL 6085001 |
| Contact | Israel Citron |
| Correspondent | Israel Citron Aspect Imaging Ltd. 27 Shaked Street Industrial Area, Hevel Modi'in, P.O. Box 926 Shoham, IS 6085001 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858755006309 | K170978 | 000 |