Cleared Traditional

K811629 - DYNA- MO

K811629 is an FDA 510(k) clearance for DYNA- MO, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K811629 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Sep 1981
Decision
91d
Days
Class 1
Risk

K811629 is an FDA 510(k) clearance for the DYNA- MO. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K811629

510(k) Number K811629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1981
Decision Date September 08, 1981
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 79
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K811629.
CARDIAC CAMERA
K833811 · Siemens Gammasonics, Inc. · Dec 1983
ADD'L TERMINAL SUPPORT FOR STAR BASIC
K820244 · General Electric Co. · Mar 1982
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC
K813073 · Technicare Corp. · Dec 1981
ROTA CAMERA
K811715 · Siemens Gammasonics, Inc. · Jul 1981
MAXI CAMERA/D
K811676 · General Electric Co. · Jul 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
K811187 · Medtronic Vascular · May 1981