Cleared Special

K040577 - SOMATOM PROJECT P30L

K040577 is an FDA 510(k) clearance for SOMATOM PROJECT P30L, manufactured by Siemens Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 18-day FDA review.

K040577 · Siemens Medical Systems, Inc. · Radiology device
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Mar 2004
Decision
18d
Days
Class 2
Risk

K040577 is an FDA 510(k) clearance for the SOMATOM PROJECT P30L. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Mavern, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 18 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Systems, Inc. devices

FDA 510(k) Submission Details - K040577

510(k) Number K040577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date March 22, 2004
Days to Decision 18 days
Submission Type Special
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
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

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 635
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