Cleared Traditional

K183548 - SOMATOM Perspective

K183548 is the FDA 510(k) clearance for SOMATOM Perspective by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K183548 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
116d
Days
Class 2
Risk

K183548 is an FDA 510(k) clearance for the SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on April 15, 2019 after a review of 116 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K183548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date April 15, 2019
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
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 K183548.
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
K183046 · Canon Medical Systems Corporation · Jun 2019
Low Dose Lung Screening Option
K190505 · Canon Medical Systems Corporation · Jun 2019
Brain Perfusion (BP) application
K182716 · Philips Medical Systems Nederland B.V. · May 2019
Deep Learning Image Reconstruction
K183202 · Ge Medical Systems, LLC · Apr 2019
Bone VCAR (BVCAR)
K183204 · GE Medical Systems SCS · Apr 2019
NewTom 5G XL
K183448 · Cefla S.C. · Mar 2019