The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Ctxx85.
| Device ID | K182147 |
| 510k Number | K182147 |
| Device Name: | CTXX85 |
| 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 | 2018-08-08 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814277020308 | K182147 | 000 |
| 00814277020162 | K182147 | 000 |
| 00814277020155 | K182147 | 000 |