Chrysalis Intelligence · Product Codes · OWB

OWB · Unclassified

121 clearances · 57 unique sponsors

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Device class
—
Regulation —
Total clearances
121
2020-01-17 → 2026-08-07
Last 12 months
19
Unique sponsors
57
Classification details
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
Siemens Medical Solutions USA, Inc. 19 3 2026-04-24
Ziehm Imaging GmbH 12 0 2025-03-17
Canon Medical Systems Corporation 6 2 2026-03-10
Philips Medical Systems Nederland B.V. 5 1 2026-08-07
Controlrad, Inc. 4 0 2021-11-24
Philips Medical Systems B.V. 3 3 2026-07-10
Radiaction , Ltd. 3 1 2026-07-31
Siemens Medical Solutions 3 0 2025-07-14
Genoray Co., Ltd. 3 1 2026-04-02
Canon, Inc. 3 1 2026-04-30
GE Medical Systems SCS 3 1 2025-12-09
Allengers Medical Systems Limited 2 0 2022-05-03
Therenva Sas 2 0 2022-10-25
Oxos Medical 2 1 2025-12-22
Portavision Medical, LLC 2 0 2021-09-24
Philips Medical Systems Nederlands B.V. 2 0 2024-05-22
Ecential Robotics 2 0 2022-04-15
DRTECH Corporation 2 0 2025-06-10
A.T.S. Applicazione Tecnologie Speciali S.R.L. 2 0 2025-04-30
Nview Medical 2 0 2022-12-28
Stephanix 2 0 2022-06-07
Medphoton GmbH 2 0 2025-03-28
Mx Imaging, Inc. 1 0 2020-05-29
Philips India Limited 1 0 2021-04-05
Surgivisio 1 0 2021-03-26
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
92004 CPT — Low Comprehensive ophthalmologic examination; established patient - not ideal but represents imaging service
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-07 K254205 Philips Medical Systems Nederland B.V. Zenition 30
2026-07-31 K260607 Radiaction , Ltd. Shield System (Siemens 30x40)
2026-07-10 K253670 Philips Medical Systems B.V. SmartCT (R3.0 (L10))
2026-05-22 K252735 Pulmera, Inc. C-beam
2026-04-30 K252503 Canon, Inc. Intelligent NR
2026-04-24 K254173 Siemens Medical Solutions USA, Inc. ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
2026-04-23 K253752 Siemens Medical Solutions USA, Inc. ARTIS genio floor; ARTIS icono.explore floor
2026-04-02 K252229 Genoray Co., Ltd. BELLIGER ACE
2026-03-24 K252099 Shimadzu Corporation Trinias
2026-03-10 K253584 Canon Medical Systems Corporation Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
2026-02-20 K252500 Cara Medical, Ltd. CARA System
2026-02-11 K251992 Savfe Co. , Ltd. ArmSure Fluoroscopic Positioning System
2026-01-16 K254186 Philips Medical Systems B.V. Azurion R3.1
2025-12-22 K252068 Oxos Medical MC2 Portable X-ray System
2025-12-16 K251893 Skanray Technologies Limited SKAN C PULSAR
2025-12-09 K251199 GE Medical Systems SCS Allia Moveo
2025-11-04 K250241 Siemens Medical Solutions USA, Inc. Cios Select
2025-10-24 K251827 Philips Medical Systems B.V. Azurion R3.1
2025-10-10 K251602 Canon Medical Systems Corporation Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
2025-07-29 K251523 Siemens Medical Solutions USA, Inc. Cios Spin
2025-07-22 K243432 Brainlab AG Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
2025-07-14 K250660 Siemens Medical Solutions LUMINOS Q.namix T; LUMINOS Q.namix R
2025-07-09 K251520 Siemens Medical Solutions USA, Inc. Cios Alpha; Cios Flow
2025-07-07 K243884 Caranx Medical TAVIPILOT
2025-06-10 K250010 DRTECH Corporation EXTRON 3; EXTRON 5; EXTRON 7
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence