The following data is part of a premarket notification filed by Cradle Technology Corp. with the FDA for Cradle Pacs.
| Device ID | K033912 |
| 510k Number | K033912 |
| Device Name: | CRADLE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CRADLE TECHNOLOGY CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min CRADLE TECHNOLOGY CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-05-11 |
| Summary: | summary |