EHD · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-02-11 → 2026-05-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Digimed Co., Ltd.	3	0	2023-03-03
VATECH Co., Ltd.	2	0	2022-10-26
Guilin Woodpecker Medical Instrument Co., Ltd.	2	1	2025-09-04
Ningbo Runyes Medical Instrument Co., Ltd.	2	1	2026-02-03
DRTECH Corporation	1	0	2024-11-01
Energy Resources International Co., Ltd. Hsinchu Branch	1	0	2022-04-04
3Dio	1	0	2023-07-06
De Götzen S.R.L.	1	0	2023-12-28
Fona S.R.L	1	0	2022-08-23
Vsi Co., Ltd.	1	0	2022-06-29
Remedi Co., Ltd.	1	0	2024-05-13
PDX Co., Ltd.	1	1	2026-05-27
Ecotron Co., Ltd.	1	0	2022-06-27
Raypia Co., Ltd.	1	0	2024-12-04
Lucas Lifecare	1	0	2024-07-05
Nanoray Co., Ltd.	1	0	2020-12-28
Shenzhen Xpectvision Technology Co., Ltd.	1	0	2024-02-08
Guilin Refine Medical Instrument Co., Ltd.	1	1	2026-02-19
Picopack Co., Ltd.	1	0	2024-07-30
Osstem Implant Co., Ltd.	1	0	2023-11-28
Alliage S/A Industrias Médico Odontológica	1	0	2024-01-03
Surround Medical Systems	1	0	2021-07-28
Genoray Co., Ltd.	1	0	2023-12-08
Changzhou Sifary Medical Technology Co., Ltd.	1	0	2023-09-01
Dental Imaging Technologies Corporation	1	1	2026-03-20

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.

Code	Type	Description	Confidence	Rationale
D0220	HCPCS	—	High	Extraoral dental X-ray imaging, standard diagnostic radiography code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-27	K260367	PDX Co., Ltd.	Portable Dental X-ray System Model PDX nova
2026-03-20	K253864	Dental Imaging Technologies Corporation	NOMAD Pro 3
2026-03-12	K252110	Guangzhou Ajax Medical Equipment Co., Ltd.	Dental X-RAY Unit (AJX200)
2026-02-19	K254018	Guilin Refine Medical Instrument Co., Ltd.	Portable Dental X-ray Device (GT-1)
2026-02-03	K252909	Ningbo Runyes Medical Instrument Co., Ltd.	Diagnostic X-Ray Equipment Model POCT22
2025-09-04	K251438	Guilin Woodpecker Medical Instrument Co., Ltd.	Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
2024-12-04	K242185	Raypia Co., Ltd.	Rextar Pro
2024-11-01	K242591	DRTECH Corporation	XERO-alpha
2024-07-30	K241963	Picopack Co., Ltd.	WERAY
2024-07-05	K241305	Lucas Lifecare	LifeRay Intraoral Handheld X-ray System
2024-05-13	K240759	Remedi Co., Ltd.	REMEX-GR100
2024-02-08	K233914	Shenzhen Xpectvision Technology Co., Ltd.	XVbeam2000
2024-01-03	K233395	Alliage S/A Industrias Médico Odontológica	Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
2023-12-28	K231055	De Götzen S.R.L.	x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
2023-12-08	K232085	Genoray Co., Ltd.	DVAS (DVAS-M, DVAS-W)
2023-11-28	K232012	Osstem Implant Co., Ltd.	N1
2023-09-01	K232068	Changzhou Sifary Medical Technology Co., Ltd.	HyperLight Portable X-ray Unit
2023-07-13	K231449	Ningbo Runyes Medical Instrument Co., Ltd.	Portable X-ray System Model Ray98(P)
2023-07-06	K223780	3Dio	Lumos 3DX
2023-03-03	K221587	Digimed Co., Ltd.	DHX-70H, XTG-70H
2023-01-17	K223010	Iray Technology Taicang , Ltd.	Portable X-ray System
2022-11-23	K222569	Guilin Woodpecker Medical Instrument Co., Ltd.	Ai Ray Dental X-Ray Device
2022-10-26	K223058	VATECH Co., Ltd.	EzRay Air 2 Wall (Model: VEX-S350W)
2022-09-01	K220579	Digimed Co., Ltd.	Hybrid C70
2022-08-23	K222274	Fona S.R.L	FONA XDC

EHD · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances