The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems, Llc) with the FDA for Signa Hero.
| Device ID | K213668 |
| 510k Number | K213668 |
| Device Name: | SIGNA Hero |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. Waukesha, WI 53188 |
| Contact | Sandra Westphal |
| Correspondent | Sandra Westphal GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278486813 | K213668 | 000 |