Chrysalis Intelligence · Product Codes · DSI

DSI · Unclassified

7 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
7
2020-03-26 → 2026-01-23
Last 12 months
1
Unique sponsors
6
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
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
iRhythm Technologies, Inc. 1 0 2024-10-30
Smartcardia SA 1 0 2023-08-30
Medicalgorithmics S.A. 1 0 2020-04-09
Preventice Technologies, Inc. 1 0 2020-03-26
Boston Scientific Cardiac Diagnostic Technologies, Inc. 1 1 2026-01-23
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