The following data is part of a premarket notification filed by Three Palm Software, Llc with the FDA for Workstationone Breast Imaging Workstation.
| Device ID | K073272 |
| 510k Number | K073272 |
| Device Name: | WORKSTATIONONE BREAST IMAGING WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | THREE PALM SOFTWARE, LLC 367 PENN WAY Los Gatos, CA 95032 |
| Contact | Heidi D Zhang |
| Correspondent | Heidi D Zhang THREE PALM SOFTWARE, LLC 367 PENN WAY Los Gatos, CA 95032 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2007-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B148WSONE1870 | K073272 | 000 |
| B148WSONE1920 | K073272 | 000 |
| B148WSONE1910 | K073272 | 000 |
| B148WSONE1900 | K073272 | 000 |
| B148WSONE1880 | K073272 | 000 |
| B109NOVAMG1840 | K073272 | 000 |
| B109NOVAMG1860 | K073272 | 000 |
| B148WSONE1810 | K073272 | 000 |
| B148WSONE1820 | K073272 | 000 |
| B148WSONE1830 | K073272 | 000 |
| B148WSONE1840 | K073272 | 000 |
| B148WSONE1850 | K073272 | 000 |
| B148WSONE1860 | K073272 | 000 |
| B148WSONE1930 | K073272 | 000 |