Company ยท CN
GE Medical Systems China Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2017. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
27recalls (4 in 12 months)
19recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 23 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 |
| MUA | Bone Sonometer | 2 |
| DPS | Electrocardiograph | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2017 | K171580 | Monitor B125, Monitor B105 Ge Medical Systems (China) Co., Ltd., CN | MHX |
| Dec 15, 2015 | K151063 | Monitor B40 Ge Medical Systems China Co., Ltd., CN | MHX |
| Dec 3, 2014 | K142288 | MAC 800 Resting ECG Analysis System Ge Medical Systems China Co., Ltd., CN | DPS |
| Feb 21, 2014 | K133576 | MONITOR B40 Ge Medical Systems China Co., Ltd. | MHX |
| Jun 26, 2013 | K130584 | MONITOR B40 Ge Medical Systems China Co., Ltd. | MHX |
| Mar 22, 2013 | K122253 | PROCARE MONITOR B20 Ge Medical Systems China Co., Ltd. | MHX |
| Feb 25, 2013 | K123238 | ACHILLES Ge Medical Systems China Co., Ltd., CN | MUA |
| Jul 19, 2012 | K120598 | PROCARE MONITOR B40 Ge Medical Systems China Co., Ltd. | MHX |
| May 11, 2011 | K103633 | ACHILLES Ge Medical Systems China Co., Ltd., CN | MUA |
| Oct 5, 2010 | K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND Ge Medical Systems China Co., Ltd., CN | IYN |
| Aug 12, 2010 | K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND Ge Medical Systems China Co., Ltd., CN | IYN |
| May 26, 2009 | K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND Ge Medical Systems China Co., Ltd., CN | IYO |
| May 5, 2009 | K091164 | GE VENUE 40, MODEL 5324338 Ge Medical Systems China Co., Ltd., CN | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | GE Medical Systems China Co., Ltd. MAC 5 A4 Resting ECG Analysis System 855001-001;
MAC 5 A5 Resting ECG Analysis System 8855002-001.
Electrocardiograph Open, Classified |
DXH | K221321 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S Open, Classified |
BSZ | K151570 K213867 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 750 A1, REF 1012-9750-000;
Carestation 750 A2, REF 1012-9750-002;
Carestation 750c A1, REF 1012-9755-000;
Open, Classified |
BSZ | K213867 |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 610 A1, REF 1012-9620-222;
Carestation 620 A1 REF 1012-9620-000;
Carestation 620 A1, REF 1012-9620-200;
C Open, Classified |
BSZ | K151570 |
| Jun 26, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers:
1) Versana Premier R3 VS, Model/Catalog Number 5938558;
2) Versana Premier R3 VA, Model/Catalog N Open, Classified |
IYN | K242005 |
| Jun 26, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system Open, Classified |
IYN | K242005 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. Open, Classified |
BSZ | K213867 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. Open, Classified |
BSZ | K213867 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. Open, Classified |
BSZ | K151570 |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems Open, Classified |
BSZ | K151570 |
| Sep 29, 2023 | GE Medical Systems China Co., Ltd. F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) Open, Classified |
MHX | K223531 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE 9100c NXT anesthesia systems Terminated |
BSZ | K151570 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 30 anesthesia systems Terminated |
BSZ | K151570 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems Terminated |
BSZ | K151570 |
| Oct 11, 2017 | GE Medical Systems China Co., Ltd. Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 Open, Classified |
BSZ | None listed |
| Oct 11, 2017 | GE Medical Systems China Co., Ltd. Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Open, Classified |
BSZ | K151570 |