Cleared Traditional

K841905 - DOT-A

K841905 is an FDA 510(k) clearance for DOT-A, manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code JWM cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K841905 · Siemens Gammasonics, Inc. · Radiology device
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Aug 1984
Decision
94d
Days
Class 2
Risk

K841905 is an FDA 510(k) clearance for the DOT-A, DOT-AR PXP-E, PXP-ER. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Walker, US). The FDA issued a Cleared decision on August 9, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1310 - 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 Gammasonics, Inc. devices

FDA 510(k) Submission Details - K841905

510(k) Number K841905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date August 09, 1984
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWM Device Classification - Class 2, Special Controls

Product Code JWM System, Tomographic, Nuclear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1310
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 - JWM System, Tomographic, Nuclear

All 14
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K841905.
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STAR
K801917 · General Electric Co. · Sep 1980