Cleared Traditional

K832737 - ECT PROCESSOR

K832737 is an FDA 510(k) clearance for ECT PROCESSOR, 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 49-day FDA review.

K832737 · Siemens Gammasonics, Inc. · Radiology device
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Sep 1983
Decision
49d
Days
Class 2
Risk

K832737 is an FDA 510(k) clearance for the ECT PROCESSOR. 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 September 29, 1983 after a review of 49 days - a notably fast clearance cycle.

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: 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 Gammasonics, Inc. devices

FDA 510(k) Submission Details - K832737

510(k) Number K832737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1983
Decision Date September 29, 1983
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 K832737.
DIGITAL GAMMA CAMERA GCA 501S
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JUMBO DIGITAL GAMMACAMERA GCA-90B
K851687 · Toshiba Medical Systems · Jun 1985
DOT-A, DOT-AR PXP-E, PXP-ER
K841905 · Siemens Gammasonics, Inc. · Aug 1984
400T ECT SOFTWARE
K812966 · General Electric Co. · Nov 1981
STAR
K801917 · General Electric Co. · Sep 1980
MODUMED MUGX
K780368 · Medtronic Vascular · Mar 1978