CARESCAPE Central Station V2— 510(k) K162012

Clearance details

Applicant

GE Healthcare

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2016-07-21

Decision date

2016-09-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Milwaukee, WI, US

• K212003 — ESSENZ Patient Monitor2021-11-10
• K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)2021-09-30
• K201162 — Essence 55SP Large Monitor System2020-08-27
• K173107 — Vios Central Station Monitor Software, Vios Central Server Software2018-07-26
• K180534 — Philips IntelliVue GuardianSoftware2018-07-16

• K253639 — View2026-01-08
• K242925 — MR Contour DL2025-04-01
• K232346 — Digital Expert Access with Remote Scanning2023-10-27
• K223212 — Precision DL2023-04-27
• K221680 — Xeleris V Processing and Review System2023-03-01

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0213-2026 — GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tubeClass II·Ongoing·Wipro GE Healthcare Private Ltd.·20250905
• Z-0214-2026 — GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tubeClass II·Ongoing·Wipro GE Healthcare Private Ltd.·20250905
• Z-1265-2022 — CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.Class II·Ongoing·GE Healthcare, LLC·20220510
• Z-0808-2022 — GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.Class II·Ongoing·GE Healthcare, LLC·20220128
• Z-0487-2018 — GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.Class II·Terminated·GE Medical Systems Information Technologies, Inc.·20180111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162012.