The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Pca-8000a, Mark 11, Pet / Ct System.
| Device ID | K082244 |
| 510k Number | K082244 |
| Device Name: | PCA-8000A, MARK 11, PET / CT SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-08-21 |
| Summary: | summary |