The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Optima Ct520.
| Device ID | K123596 |
| 510k Number | K123596 |
| Device Name: | OPTIMA CT520 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO. 2 N. YONGCHANG STREET BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA Beijing, CN 100176 |
| Contact | Helen Peng |
| Correspondent | Helen Peng GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO. 2 N. YONGCHANG STREET BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA Beijing, CN 100176 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682147415 | K123596 | 000 |
| 00840682102568 | K123596 | 000 |
| 00195278403087 | K123596 | 000 |
| 00195278385215 | K123596 | 000 |