Chrysalis Intelligence · Product Codes · IWB

IWB · System, Radiation Therapy, Radionuclide

Radiology · 6 clearances · 3 unique sponsors

Device class
Class II
Regulation 892.5750
Total clearances
6
2020-02-04 → 2025-07-02
Last 12 months
0
Unique sponsors
3
Medical specialty
Radiology
Review panel
RA
Regulation number
892.5750
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Elekta Solutions AB 3 0 2025-07-02
Akesis, Inc. 2 0 2021-03-05
Our United Corporation 1 0 2021-03-12
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
77790 CPT High Brachytherapy; clinical brachytherapy planning
77799 CPT Medium Unlisted radiotherapy procedure for radionuclide therapy systems
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-02 K250391 Elekta Solutions AB Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
2024-02-08 K232854 Elekta Solutions AB Leksell GammaPlan (LGP)
2022-10-26 K222047 Elekta Solutions AB Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
2021-03-12 K203250 Our United Corporation TaiChiC
2021-03-05 K203146 Akesis, Inc. Akesis Galaxy RTi
2020-02-04 K200050 Akesis, Inc. Akesis Galaxy RTx