Chrysalis Intelligence · Product Codes · DSI

DSI · Detector And Alarm, Arrhythmia

Cardiovascular · 7 clearances · 6 unique sponsors

Device class
Class II
Regulation 870.1025
Total clearances
7
2020-03-26 → 2026-01-23
Last 12 months
1
Unique sponsors
6
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1025
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
Infobionic, Inc. 2 0 2025-07-29
Boston Scientific Cardiac Diagnostic Technologies, Inc. 1 1 2026-01-23
Medicalgorithmics S.A. 1 0 2020-04-09
Preventice Technologies, Inc. 1 0 2020-03-26
iRhythm Technologies, Inc. 1 0 2024-10-30
Smartcardia SA 1 0 2023-08-30
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
93000 CPT — High Standard cardiac monitoring with arrhythmia detection and alarm functionality
93042 CPT — Medium Rhythm strip with arrhythmia interpretation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-23 K243349 Boston Scientific Cardiac Diagnostic Technologies, Inc. BodyGuardian Remote Monitoring System (BGRMS v3.0)
2025-07-29 K250356 Infobionic, Inc. MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
2024-10-30 K240177 iRhythm Technologies, Inc. Zio AT® device (A100A1001)
2023-10-06 K230265 Infobionic, Inc. MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
2023-08-30 K231276 Smartcardia SA SmartCardia 7L Platform
2020-04-09 K193104 Medicalgorithmics S.A. Unified Arrhythmia Diagnostic System PocketECG IV
2020-03-26 K192732 Preventice Technologies, Inc. BodyGuardian Remote Monitoring System