Cleared Traditional

K811842 - IMAGER 2000 REAL TIME SYSTEM

K811842 is an FDA 510(k) clearance for IMAGER 2000 REAL TIME SYSTEM, manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K811842 · Siemens Gammasonics, Inc. · Radiology device
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Nov 1981
Decision
142d
Days
Class 2
Risk

K811842 is an FDA 510(k) clearance for the IMAGER 2000 REAL TIME SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 - K811842

510(k) Number K811842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date November 20, 1981
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 436
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K811842.
SINUSCOPE
K812686 · Jedmed Instrument Co. · Mar 1982
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K820124 · Siemens Gammasonics, Inc. · Mar 1982
DATAPASS
K812435 · General Electric Co. · Jan 1982
FETAL VITABILITY TM MODE
K812743 · Technicare Corp. · Nov 1981
LINUS
K812398 · Fischer Imaging Corp. · Nov 1981
DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING
K812014 · Elscint, Inc. · Sep 1981