The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Critical Care Suite.
| Device ID | K183182 |
| 510k Number | K183182 |
| Device Name: | Critical Care Suite |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Contact | Camille Vidal |
| Correspondent | Camille Vidal GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha, WI 53188 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146340 | K183182 | 000 |
| 00840682147231 | K183182 | 000 |
| 00195278217981 | K183182 | 000 |