Chrysalis Intelligence · Product Codes · KGI

KGI · Densitometer, Bone

Radiology · 7 clearances · 6 unique sponsors

Device class
Class II
Regulation 892.1170
Total clearances
7
2022-07-29 → 2026-04-20
Last 12 months
2
Unique sponsors
6
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1170
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
3D-Shaper Medical S.L 2 1 2025-09-05
Medimaps Group SA 1 0 2025-01-17
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 1 1 2026-04-20
O.N. Diagnostics 1 0 2023-05-19
BunkerHill Health 1 0 2025-04-08
HeartLung Corporation 1 0 2022-07-29
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
76977 CPT High Standard CPT for dual-energy x-ray absorptiometry (DXA) bone density measurement
E1070 HCPCS Fully-reclining wheelchair, detachable arms (desk or full length) swing away detachable footrest ✓ CMS-verified description Medium HCPCS code for bone density measurement device rental/supply
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-20 K252718 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Lunar Astra
2025-09-05 K251022 3D-Shaper Medical S.L 3D-SHAPER
2025-04-08 K242295 BunkerHill Health BunkerHill BMD
2025-01-17 K243218 Medimaps Group SA TBS iNsight (V4)
2023-05-19 K220402 O.N. Diagnostics VirtuOst
2022-12-09 K220822 3D-Shaper Medical S.L 3D-SHAPER
2022-07-29 K213760 HeartLung Corporation ABMD Software