Device class
Class II
Regulation 892.5730
Total clearances
7
2020-01-23 → 2025-12-05
Classification details
Medical specialty
Radiology
Regulation number
892.5730
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Gt Medical Technologies |
2 |
0 |
2022-11-09 |
|
Oncopatch, Inc. |
1 |
1 |
2025-12-05 |
|
Radiance Therapeutics, Inc. |
1 |
0 |
2023-01-11 |
|
Isoaid, LLC |
1 |
0 |
2025-07-15 |
|
Lv Liberty Vision Corporation |
1 |
0 |
2020-05-29 |
|
Isoray Medical, Inc. |
1 |
0 |
2020-12-31 |
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 |
| 77790 |
CPT
|
— |
High
|
Standard CPT for brachytherapy radioactive source calibration/assay |
| C1643 |
HCPCS
|
— |
Medium
|
HCPCS for radioelement implant codes (brachytherapy source) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-05 |
K252296 |
Oncopatch, Inc.
|
OncoPatch |
| 2025-07-15 |
K242818 |
Isoaid, LLC
|
IsoSphere |
| 2023-01-11 |
K223465 |
Radiance Therapeutics, Inc.
|
RadianceTx Radionuclide Brachytherapy Source |
| 2022-11-09 |
K221539 |
Gt Medical Technologies
|
GammaTile |
| 2020-12-31 |
K202267 |
Isoray Medical, Inc.
|
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles |
| 2020-05-29 |
K193602 |
Lv Liberty Vision Corporation
|
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source |
| 2020-01-23 |
K190839 |
Gt Medical Technologies
|
GammaTile |