Cleared Traditional

K790975 - SOMATOM 2

K790975 is the FDA 510(k) clearance for SOMATOM 2 by Siemens Corp.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K790975 · Siemens Corp. · Radiology device
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Jul 1979
Decision
68d
Days
Class 2
Risk

K790975 is an FDA 510(k) clearance for the SOMATOM 2. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Corp. (Walker, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 68 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 Siemens Corp. devices

Submission Details

510(k) Number K790975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1979
Decision Date July 30, 1979
Days to Decision 68 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 107d · This submission: 68d
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 608
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K790975.
SYNERVIEW MODEL 6545
K801407 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
ACTA-SCANNER 0220FS
K791153 · Pfizer, Inc. · Aug 1979
PFIZER 0200FS LOCALLZER
K791163 · Pfizer, Inc. · Aug 1979
RADVIEW IMAGER SYSTEM
K790942 · General Electric Co. · Jun 1979
SOMATOM SD
K790342 · Siemens Corp. · Mar 1979
RADIOTHERAPY TREATMENT
K790134 · General Electric Co. · Feb 1979