The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Dpx Tissue Quantification Output.
| Device ID | K935454 |
| 510k Number | K935454 |
| Device Name: | DPX TISSUE QUANTIFICATION OUTPUT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
| Contact | Richard B Mazess |
| Correspondent | Richard B Mazess LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1995-10-19 |