The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Aw Volumeshare 5 With Angioviz Option.
| Device ID | K110834 |
| 510k Number | K110834 |
| Device Name: | AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 3000 NORTH.GRANDVIEW BLVD. W1140 Waukesha, WI 53188 |
| Contact | Helen Peng |
| Correspondent | Helen Peng GE HEALTHCARE 3000 NORTH.GRANDVIEW BLVD. W1140 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-25 |
| Decision Date | 2011-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102278 | K110834 | 000 |