The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Lung Volume Analysis.
| Device ID | K113715 |
| 510k Number | K113715 |
| Device Name: | LUNG VOLUME ANALYSIS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-08-17 |
| Summary: | summary |