The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Dot-a, Dot-ar Pxp-e, Pxp-er.
| Device ID | K841905 |
| 510k Number | K841905 |
| Device Name: | DOT-A, DOT-AR PXP-E, PXP-ER |
| Classification | System, Tomographic, Nuclear |
| Applicant | SIEMENS GAMMASONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JWM |
| CFR Regulation Number | 892.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-08-09 |