The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Customer Remote Console (crc).
| Device ID | K150193 |
| 510k Number | K150193 |
| Device Name: | Customer Remote Console (CRC) |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John W. Jaeckle |
| Correspondent | Elizabeth Mathew GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-28 |
| Decision Date | 2015-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278263919 | K150193 | 000 |