JAK · Class II · 21 CFR 892.1750

FDA Product Code JAK: System, X-ray, Tomography, Computed

FDA product code JAK covers computed tomography (CT) systems.

These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.

JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Medical Systems, In.C and General Electric Co..

827

Total

827

Cleared

108d

Avg days

1976

Since

Stable submission activity - 51 submissions in the last 2 years

Review times increasing: avg 158d recently vs 105d historically

FDA 510(k) Cleared System, X-ray, Tomography, Computed Devices (Product Code JAK)

827 devices

1–24 of 827

1 2 3 4

Cleared Oct 16, 2026

AVIEW Aorta Metrics

K260391

Coreline Soft Co., Ltd.

Samsung HME America, Inc., dba NeuroLogica Corp.

Radiology · 169d

Cleared Sep 18, 2026

SCENARIA View Phase 6.0

BodyTom Elite (NL4000)

K253450

NeuroLogica Corp., a Samsung Company

GE Medical Systems SCS

Radiology · 237d

Cleared Jun 24, 2026

Enhanced Boundary for PCCT

K253560

Ge Medical Systems, LLC

Radiology · 219d

Cleared Jun 04, 2026

Respiratory Gating for Scanners (2.1)

K253026

Varian Medical Systems, Inc.

Radiology · 258d

Cleared May 20, 2026

Aquilion ONE (TSX-308A/TSX-306A) V2.0

K253596

Canon Medical Systems Corporation

Radiology · 183d

Cleared Mar 27, 2026

Spectral CT Verida Family

K253649

Philips Medical Systems Technologies , Ltd.

Philips Healthcare (Suzhou) Co., Ltd.

Ge Healthcare Japan Corporation

Radiology · 122d

Cleared Mar 20, 2026

Photonova Spectra, Photonova Spectra Select

K253520

Ge Medical Systems, LLC

Siemens Medical Solutions USA, Inc.

Radiology · 123d

Cleared Mar 13, 2026

Extremity CT Imaging System

K252249

Mars Bioimaging , Ltd.

Radiology · 238d

Cleared Mar 13, 2026

Aquilion ServeSP (TSX-307B) V2.0

K260078

Canon Medical Systems Corporation

Radiology · 60d

Cleared Mar 06, 2026

Bunkerhill Contrast CAC

Bunkerhill Contrast AVC

Philips Medical Systems Nederland B.V.

Radiology · 44d

Cleared Jan 20, 2026

uCT 780 with uWS-CT-Dual Energy Analysis

K253173

Shanghai United Imaging Healthcare Co., Ltd.

Canon Medical Informatics, Inc.

Siemens Medical Solutions USA, Inc.

1 2 3 4

About Product Code JAK - Regulatory Context

510(k) Submission Activity

827 total 510(k) submissions under product code JAK since 1976, with 827 receiving FDA clearance (average review time: 108 days).

Submission volume has remained relatively stable over the observed period, with 51 submissions in the last 24 months.

FDA 510(k) Review Time - JAK Product Code

Recent submissions under JAK have taken an average of 158 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.

JAK devices are reviewed by the Radiology panel. Browse all Radiology devices →

FDA Product Code JAK: System, X-ray, Tomography, Computed

FDA 510(k) Cleared System, X-ray, Tomography, Computed Devices (Product Code JAK)

About Product Code JAK - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - JAK Product Code

Related FDA 510(k) Regulatory Insights