The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Achieva R4 1.5t And Achieva R4 3.0t.
| Device ID | K110151 |
| 510k Number | K110151 |
| Device Name: | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS HEALTHCARE 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS HEALTHCARE 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-01-18 |
| Decision Date | 2011-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082625 | K110151 | 000 |
| 00884838082618 | K110151 | 000 |
| 00884838068490 | K110151 | 000 |
| 00884838055339 | K110151 | 000 |