Carescape Canvas 1000; Carescape Canvas Smart Display— 510(k) K260343
Substantially EquivalentGE Healthcare Finland Oy
FDA 510(k) clearance K260343 for Carescape Canvas 1000; Carescape Canvas Smart Display, Substantially Equivalent on 2026-08-28. Applicant: GE Healthcare Finland Oy. Device class: 2.
Summary
GE Healthcare Finland's submission lists the Carescape Canvas 1000 and the Carescape Canvas Smart Display. The product code is MHX, physiological patient monitors with arrhythmia detection or alarms.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
GE Healthcare Finland filed from Helsinki, Finland. The decision came 207 calendar days after FDA received it (February 2 to August 28, 2026): substantially equivalent.
Clearance details
- Applicant
- GE Healthcare Finland Oy
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, FI
Recent devices under product code MHX
view allMore clearances from GE Healthcare Finland Oy
view all- K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
- K213181 — CARESCAPE B650, E-musb
- K213336 — Carescape B850, E-musb
- K213363 — CARESCAPE B450, E-musb
- K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.