Chrysalis Intelligence · Product Codes · JAK

JAK · System, X-Ray, Tomography, Computed

Radiology · 176 clearances · 56 unique sponsors

Device class
Class II
Regulation 892.1750
Total clearances
176
2020-01-16 → 2026-07-28
Last 12 months
23
Unique sponsors
56
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1750
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
Siemens Medical Solutions USA, Inc. 30 2 2026-03-20
Canon Medical Systems Corporation 18 3 2026-05-20
Shanghai United Imaging Healthcare Co., Ltd. 10 1 2026-01-20
GE Medical Systems SCS 9 1 2026-07-21
Ge Medical Systems, LLC 9 2 2026-06-24
Philips Medical Systems Nederland B.V. 7 1 2026-03-05
Ge Healthcare Japan Corporation 7 1 2026-03-23
Philips Healthcare (Suzhou) Co., Ltd. 6 1 2026-03-23
BunkerHill Health 5 3 2026-03-06
Arineta , Ltd. 4 0 2025-04-15
Clear Guide Medical 3 0 2024-01-17
Neurologica Corporation 3 1 2025-09-08
Xact Robotics, Ltd. 3 0 2022-09-23
Philips Medical Systems Technologies , Ltd. 3 1 2026-03-27
Varian Medical Systems, Inc. 3 1 2026-06-04
Canon Medical Informatics, Inc. 3 1 2025-11-28
Isys Medizintechnik GmbH 2 0 2023-10-10
Ge Hangwei Medical Systems Co., Ltd. 2 0 2024-02-22
Nano-X AI , Ltd. 2 0 2024-08-19
Philips Ultrasound, Inc. 2 0 2023-01-18
Brainomix Limited 2 0 2025-02-19
Neurologica Corporation, A Subsidiary of Samsung Electronics 2 0 2022-02-25
4Dmedical Limited 2 1 2025-08-28
Siemens Healthcare GmbH 2 0 2024-03-21
FUJIFILM Healthcare Americas Corporation 2 0 2024-04-26
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
71260 CPT High CT chest; computed tomography is standard imaging modality billed by anatomic site
70450 CPT Medium CT head; CT systems bill by anatomic region
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-28 K253450 NeuroLogica Corp., a Samsung Company BodyTom Elite (NL4000)
2026-07-21 K253770 GE Medical Systems SCS CardIQ Suite
2026-06-24 K253560 Ge Medical Systems, LLC Enhanced Boundary for PCCT
2026-06-04 K253026 Varian Medical Systems, Inc. Respiratory Gating for Scanners (2.1)
2026-05-20 K253596 Canon Medical Systems Corporation Aquilion ONE (TSX-308A/TSX-306A) V2.0
2026-03-27 K253649 Philips Medical Systems Technologies , Ltd. Spectral CT Verida Family
2026-03-23 K253686 Ge Healthcare Japan Corporation True Definition DL
2026-03-23 K252992 Philips Healthcare (Suzhou) Co., Ltd. CT Rembra RT; CT Areta RT; CT Rembra
2026-03-20 K253574 Siemens Medical Solutions USA, Inc. SOMATOM X.cite; SOMATOM X.ceed
2026-03-20 K253520 Ge Medical Systems, LLC Photonova Spectra, Photonova Spectra Select
2026-03-13 K260078 Canon Medical Systems Corporation Aquilion ServeSP (TSX-307B) V2.0
2026-03-13 K252249 Mars Bioimaging , Ltd. Extremity CT Imaging System
2026-03-06 K260167 BunkerHill Health Bunkerhill Contrast AVC
2026-03-06 K260166 BunkerHill Health Bunkerhill Contrast CAC
2026-03-05 K260169 Philips Medical Systems Nederland B.V. AV Cardiac CT
2026-01-20 K253173 Shanghai United Imaging Healthcare Co., Ltd. uCT 780 with uWS-CT-Dual Energy Analysis
2025-11-28 K252217 Canon Medical Informatics, Inc. CT VScore+
2025-10-15 K251805 Siemens Medical Solutions USA, Inc. syngo.CT Dual Energy
2025-10-03 K250662 BunkerHill Health Bunkerhill MAC
2025-10-02 K250766 Thirona BV LungQ 4
2025-09-26 K251645 Canon Medical Systems Corporation Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
2025-09-08 K250928 Neurologica Corporation OmniTom Elite with PCD
2025-08-28 K251484 4Dmedical Limited CT:VQ
2025-08-01 K250941 Ge Medical Systems, LLC Revolution Vibe
2025-07-28 K251061 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime