Chrysalis Intelligence · Product Codes · SDJ

SDJ · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2024-11-15 → 2025-06-20
Last 12 months
0
Unique sponsors
3
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
InVision Medical Technology Corporation 1 0 2025-05-21
Ultromics Limited 1 0 2024-11-15
Eko.Ai Pte Ltd. D/B/A Us2.Ai 1 0 2025-06-20
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
93040 CPT Low Cardiac indicator device; adjunctive amyloidosis detection may use echocardiography or imaging-based billing codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-06-20 K250151 Eko.Ai Pte Ltd. D/B/A Us2.Ai Us2.ca
2025-05-21 K243866 InVision Medical Technology Corporation InVision Precision Cardiac Amyloid
2024-11-15 K240860 Ultromics Limited EchoGo Amyloidosis (1.0)