The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Computed Radiography Quality Assurance Software.
| Device ID | K980168 |
| 510k Number | K980168 |
| Device Name: | COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | ANALOGIC CORP. 86 BOSTON POST RD. Waterford, CT 06385 |
| Contact | Ronald Luich |
| Correspondent | Ronald Luich ANALOGIC CORP. 86 BOSTON POST RD. Waterford, CT 06385 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-02 |