Chrysalis Intelligence · Product Codes · QJU

QJU · Unclassified

9 clearances · 5 unique sponsors

Device class
Regulation —
Total clearances
9
2020-02-07 → 2026-07-15
Last 12 months
3
Unique sponsors
5
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
Caption Health 3 0 2025-01-15
Ultrasight , Ltd. 2 1 2025-12-17
Deski 2 1 2026-06-03
ThinkSono GmbH 1 1 2026-07-15
Bay Labs, Inc. 1 0 2020-02-07
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
76376 CPT Medium 3D image reconstruction/processing for radiology; applicable for AI-guided acquisition
76998 CPT Medium Ultrasound guidance software/AI optimization may be ancillary to imaging codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-15 K260338 ThinkSono GmbH ThinkSono Guidance
2026-06-03 K260780 Deski HeartFocus
2025-12-17 K251416 Ultrasight , Ltd. UltraSight Guidance
2025-04-04 K242807 Deski HeartFocus (V.1.1.1)
2025-01-15 K243065 Caption Health, Inc. Cardiac Guidance
2023-07-24 K223347 Ultrasight, Inc. UltraSight AI Guidance
2020-09-18 K201992 Caption Health Caption Guidance
2020-04-16 K200755 Caption Health Caption Guidance
2020-02-07 DEN190040 Bay Labs, Inc. Caption Guidance