FDA 510(k) Applications Submitted by Joseph Chang
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220264 |
01/31/2022 |
EFAI RTSuite CT HN-Segmentation System |
Ever Fortune.AI Co., Ltd. |
| K240291 |
02/01/2024 |
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM |
Ever Fortune.AI, Co., Ltd. |
| K231025 |
04/11/2023 |
EFAI NeuroSuite CT ICH Assessment System |
Ever Fortune.AI Co., Ltd. |
| K221552 |
05/31/2022 |
EFAI ChestSuite XR Pneumothorax Assessment System |
Ever Fortune AI Co., Ltd. |
| K231928 |
06/30/2023 |
EFAI RTSUITE CT HCAP-Segmentation System |
Ever Fortune.AI Co., Ltd. |
| K222076 |
07/14/2022 |
EFAI ChestSuite XR Pleural Effusion Assessment System |
Ever Fortune.AI Co., Ltd. |
| K232100 |
07/14/2023 |
Efai Pacs Picture Archiving and Communication System Pro |
Ever Fortune.AI Co., Ltd. |
| K242921 |
09/24/2024 |
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostom |
Vitaltec Corporation |
| K234042 |
12/21/2023 |
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) |
Ever Fortune.AI Co., Ltd. |
| K090309 |
02/06/2009 |
LAGIS ENDOSCOPIC INSTRUMENTS |
LAGIS ENTERPRISES CO, LTD. |
| K090727 |
03/19/2009 |
IMM DENTAL IRRIGATION TUBING SET |
INNOVATIVE MEDICAL MANUFACTURING CO. |
| K070801 |
03/23/2007 |
IMM HYPODERMIC NEEDLE SET |
INNOVATIVE MEDICAL MANUFACTURING CO. |
| K061626 |
06/12/2006 |
VASORING* VRC VASCULAR RING CONNECTOR |
SUNWEI TECH CO. LTD. |
| K031830 |
06/13/2003 |
SAFEPRO PLUS SAFETY SYRINGE |
FORMOSA MEDICAL DEVICES, INC. |
| K022063 |
06/25/2002 |
SAFEPRO SAFETY SYRINGE |
FORMOSA MEDICAL DEVICES, INC. |
| K122152 |
07/20/2012 |
OXTI INFLATION DEVICE |
OXTI CORPORATION |
| K012726 |
08/15/2001 |
PROSAFE SAFETY SYRINGE |
HOU-SE MEDICAL INC |
| K082460 |
08/26/2008 |
CENEFOM PVA SURGICAL SPEAR |
LONGTEK SCIENTIFIC CO., LTD. |
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