The following data is part of a premarket notification filed by Medical Standard Co., Ltd. with the FDA for Pacs Plus 5th Edition.
| Device ID | K083658 |
| 510k Number | K083658 |
| Device Name: | PACS PLUS 5TH EDITION |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDICAL STANDARD CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90638 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi MEDICAL STANDARD CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90638 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-10 |
| Decision Date | 2009-07-07 |
| Summary: | summary |