The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Surgical Microscope System Orbeye With Ir.
| Device ID | K190772 |
| 510k Number | K190772 |
| Device Name: | SURGICAL MICROSCOPE SYSTEM ORBEYE With IR |
| Classification | System, X-ray, Angiographic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-03-26 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170396083 | K190772 | 000 |
| 04953170395994 | K190772 | 000 |
| 04953170424724 | K190772 | 000 |
| 04953170396113 | K190772 | 000 |