Chrysalis Intelligence · Product Codes · QEB

QEB · Ventilatory Electrical Impedance Tomograph

Anesthesiology · 5 clearances · 3 unique sponsors

Device class
Class II
Regulation 868.1505
Total clearances
5
2022-01-06 → 2025-09-10
Last 12 months
1
Unique sponsors
3
Definition

What is Ventilatory Electrical Impedance Tomograph

A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax.
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.1505
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Timpel S.A. 3 1 2025-09-10
Sentec AG 1 0 2025-08-07
Bilab 1 0 2023-06-30
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94004 CPT Medium Ventilation assessment by non-invasive monitoring device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-10 K250464 Timpel S.A. Enlight 2100 (TPL-E2103-0)
2025-08-07 K243765 Sentec AG LuMon(TM) System
2023-06-30 K222466 Bilab AirTom
2023-03-07 K222897 Timpel S.A. Enlight 2100
2022-01-06 K211135 Timpel S.A. Enlight 2100