IYE · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

101

2020-01-03 → 2026-08-03

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
Varian Medical Systems, Inc.	21	4	2026-08-03
Brainlab AG	8	0	2025-06-23
Vision Rt, Ltd.	7	1	2026-03-18
Elekta Solutions AB	5	1	2026-01-15
Macromedics BV	4	0	2025-03-19
Radformation, Inc.	4	2	2026-04-03
Accuray Incorporated	3	0	2023-06-23
Klarity Medical & Equipment (GZ) Co., Ltd.	3	0	2025-03-18
Lap GmbH Laser Applikationen	3	1	2026-06-04
Manteia Technologies Co., Ltd.	2	1	2025-10-24
Doseoptics, LLC	2	0	2021-09-15
Naslund Medical AB	2	0	2022-01-06
C-Rad Positioning AB	2	0	2020-05-07
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla	2	1	2026-04-15
Our United Corporation	2	0	2021-11-02
Ptw-Freiburg Physikalisch-Technische-Werkstaetten	2	0	2022-03-30
Dosisoft SA	2	1	2026-06-12
Qfix	2	0	2023-03-31
Panacea Medical Technologies Pvt. , Ltd.	2	0	2023-06-08
Zap Surgical Systems, Inc.	2	1	2025-11-03
Prowess, Inc.	1	0	2021-09-28
Blessing Cathay Corporation	1	1	2025-09-03
Elekta Limited	1	0	2021-06-11
Medtec, Inc. Dba Civco Medical Solutions and Civco	1	0	2021-05-20
Wisdom Technologies., Inc.	1	0	2024-01-05

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
77799	CPT	—	High	Unlisted radiotherapy procedure; linear accelerators are treatment equipment not directly billable

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-03	K261856	Varian Medical Systems, Inc.	Halcyon, Ethos Radiotherapy System (5.0)
2026-06-12	K252937	Dosisoft SA	ThinkQA 3
2026-06-04	K253004	Lap GmbH Laser Applikationen	LUNA 3D
2026-05-08	K260792	Stabilix, LLC	AerFrame Patient Immobilization System (AFPIS)
2026-04-15	K252258	Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla	VERIQA RT EPID 3D
2026-04-03	K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)
2026-03-18	K253012	Vision Rt, Ltd.	AlignRT Plus (8.0)
2026-01-21	K252977	Varian Medical Systems, Inc.	Halcyon, Ethos Radiotherapy System (5.0)
2026-01-15	K252188	Elekta Solutions AB	EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
2026-01-14	K254010	Brainlab SE	ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
2026-01-05	K252988	Radformation, Inc.	ChartCheck (RADCH V1.6)
2025-12-16	K252919	Varian Medical Systems, Inc.	IDENTIFY (5.0)
2025-11-03	K250392	Zap Surgical Systems, Inc.	ZAP-X Radiosurgery System (ZAP-X)
2025-10-24	K250696	Manteia Technologies Co., Ltd.	AccuCheck
2025-10-17	K250911	Electrogenics Labs, Ltd.	MOSkin Radiation Measurement System
2025-10-07	K252948	Varian Medical Systems, Inc.	TrueBeam, TrueBeam STX, Edge and VitalBeam
2025-09-03	K252174	Blessing Cathay Corporation	AquaCast Mask
2025-06-23	K243142	Brainlab AG	Cranial 4Pi Immobilization
2025-05-19	K243301	Vision Rt, Ltd.	MapRT
2025-05-16	K250099	Varian Medical Systems	Mobius3D (4.1)
2025-03-19	K250429	Macromedics BV	DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
2025-03-18	K241937	Klarity Medical & Equipment (GZ) Co., Ltd.	Klarity SGRT System (ARSG-E1A, ARSG-E3A)
2025-02-07	K242957	Varian Medical Systems, Inc.	Identify (4.0)
2024-07-24	K240431	Brainlab AG	ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
2024-05-31	K232738	Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla	BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

IYE · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances