The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera 4k Uhd System.
| Device ID | K151011 |
| 510k Number | K151011 |
| Device Name: | VISERA 4K UHD SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Daphney Germain-kolawole Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | HET |
| Subsequent Product Code | EOB |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170374692 | K151011 | 000 |
| 04953170374685 | K151011 | 000 |
| 04953170374678 | K151011 | 000 |
| 04953170374630 | K151011 | 000 |
| 04953170374623 | K151011 | 000 |
| 04953170374609 | K151011 | 000 |
| 04953170374579 | K151011 | 000 |
| 04953170374531 | K151011 | 000 |