The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Synerad Impact 60, Synerad Impact 72 And Analogic Ams1600.
| Device ID | K052447 |
| 510k Number | K052447 |
| Device Name: | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. CENTENNIAL INDUSTRIAL PARK Peabody, MA 01960 |
| Contact | Donald Sherratt |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2005-09-21 |
| Summary: | summary |