Chrysalis Intelligence · Product Codes · QBS

QBS · Unclassified

9 clearances · 7 unique sponsors

Device class
Regulation —
Total clearances
9
2020-07-30 → 2026-05-12
Last 12 months
1
Unique sponsors
7
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
Azmed Sas 2 0 2024-07-17
Gleamer 2 0 2023-03-02
Ge Medical Systems, LLC 1 0 2023-05-25
Icometrix NV 1 0 2024-11-07
Milvue 1 0 2025-01-17
Imagen Technologies, Inc. 1 0 2020-07-30
AZmed 1 1 2026-05-12
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
70450 CPT Low CT head/brain; computer assisted detection may accompany imaging
71020 CPT Low Chest radiography; CAD software applies to radiography
99457 CPT Low Remote monitoring/clinical assessment; may support diagnostic interpretation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-12 K260378 AZmed Rayvolve
2025-01-17 K242171 Milvue TechCare Trauma
2024-11-07 K240712 Icometrix NV icobrain aria
2024-07-17 K240845 Azmed Sas Rayvolve
2023-05-25 K223491 Ge Medical Systems, LLC Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
2023-03-02 K222176 Gleamer BoneView
2022-06-02 K220164 Azmed Sas Rayvolve
2022-03-01 K212365 Gleamer BoneView
2020-07-30 K193417 Imagen Technologies, Inc. FractureDetect (FX)