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 |