Cleared Traditional

K220664 - NewTom 7G

K220664 is the FDA 510(k) clearance for NewTom 7G by Cefla S.C.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K220664 · Cefla S.C. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
60d
Days
Class 2
Risk

K220664 is an FDA 510(k) clearance for the NewTom 7G. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on May 6, 2022 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cefla S.C. devices

Submission Details

510(k) Number K220664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date May 06, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K220664.
syngo.CT CaScoring
K221219 · Siemens Medical Solutions USA, Inc. · May 2022
Spectral CT on Rails
K212875 · Philips Medical Systems Nederland B.V. · May 2022
XACT ACE Robotic System
K221116 · Xact Robotics, Ltd. · May 2022
Liver Suite
K211180 · GE Medical Systems SCS · May 2022
BodyTom 64
K213649 · Neurologica Corporation · Apr 2022
Philips Incisive CT
K212441 · Philips Healthcare (Suzhou) Co., Ltd. · Apr 2022