Chrysalis Intelligence · Product Codes · OEB

OEB · Unclassified

11 clearances · 9 unique sponsors

Device class
Regulation —
Total clearances
11
2020-03-09 → 2026-05-27
Last 12 months
2
Unique sponsors
9
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
Coreline Soft Co., Ltd. 2 1 2025-12-03
Siemens Healthcare GmbH 2 0 2023-07-19
V5med, Inc. 1 0 2025-03-27
MeVis Medical Solutions AG 1 0 2021-02-23
Riverain Technologies, Inc. 1 0 2022-12-05
Fujifilm Corporation 1 1 2026-05-27
Siemens Medi Cal Solutions, Inc. 1 0 2020-03-09
Infervision Medical Technology Co., Ltd. 1 0 2025-05-16
Beijing Infervision Technology Co., Ltd. 1 0 2020-07-02
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
71046 CPT Medium CT chest with CAD for pulmonary nodule detection; computer-aided detection may be billed separately or bundled
0174T CPT Low Computer-aided detection CAD add-on code (older, may not apply to CT lung systems)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-27 K254075 Fujifilm Corporation Synapse Lung Nodule AI
2025-12-03 K251203 Coreline Soft Co., Ltd. AVIEW Lung Nodule CAD
2025-05-16 K240554 Infervision Medical Technology Co., Ltd. InferRead Lung CT.AI
2025-03-27 K242919 V5med, Inc. V5med Lung AI
2023-07-19 K231157 Siemens Healthcare GmbH syngo.CT Lung CAD (Version VD30)
2023-02-24 K221592 Coreline Soft Co., Ltd. AVIEW Lung Nodule CAD
2022-12-05 K221612 Riverain Technologies, Inc. ClearRead CT
2021-03-31 K203258 Siemens Healthcare GmbH syngo.CT Lung CAD
2021-02-23 K201501 MeVis Medical Solutions AG Veolity
2020-07-02 K192880 Beijing Infervision Technology Co., Ltd. InferRead Lung CT.AI
2020-03-09 K193216 Siemens Medi Cal Solutions, Inc. syngo.CT Lung CAD