The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Ct6485, Ct12885.
Device ID | K172058 |
510k Number | K172058 |
Device Name: | CT6485, CT12885 |
Classification | System, X-ray, Tomography, Computed |
Applicant | Analogic Corporation 8 Centennial Drive Peabody, MA 01960 |
Contact | Karen Provencher |
Correspondent | Karen Provencher Analogic Corporation 8 Centennial Drive Peabody, MA 01960 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-06 |
Decision Date | 2018-02-13 |
Summary: | summary |