Cleared Special

K241440 - HealthCCSng (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241440 · Nano-X AI , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
90d
Days
Class 2
Risk

K241440 is an FDA 510(k) clearance for the HealthCCSng. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Nano-X AI , Ltd. (Petah Tikva, IL). The FDA issued a Cleared decision on August 19, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nano-X AI , Ltd. devices

Submission Details

510(k) Number K241440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2024
Decision Date August 19, 2024
Days to Decision 90 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 816
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K241440.
Spectral CT Verida Family
K253649 · Philips Medical Systems Technologies , Ltd. · Mar 2026
CT Rembra RT
K252992 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
True Definition DL
K253686 · Ge Healthcare Japan Corporation · Mar 2026
Photonova Spectra, Photonova Spectra Select
K253520 · Ge Medical Systems, LLC · Mar 2026
SOMATOM X.cite
K253574 · Siemens Medical Solutions USA, Inc. · Mar 2026
Extremity CT Imaging System
K252249 · Mars Bioimaging , Ltd. · Mar 2026