Cleared Traditional

K884673 - APEX 215M MOBILE ANGER CAMERA

K884673 is the FDA 510(k) clearance for APEX 215M MOBILE ANGER CAMERA by Elscint, Inc.. It is a Class 1 Radiology device (product code IYX) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K884673 · Elscint, Inc. · Radiology device
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Apr 1989
Decision
157d
Days
Class 1
Risk

K884673 is an FDA 510(k) clearance for the APEX 215M MOBILE ANGER CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Elscint, Inc. (Boston, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 157 days - an extended review cycle.

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 Elscint, Inc. devices

Submission Details

510(k) Number K884673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date April 14, 1989
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K884673.
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672 · Elscint, Inc. · Apr 1989
APEX 415 ANGER CAMERA
K884674 · Elscint, Inc. · Apr 1989
APEX 609R ANGER CAMERA
K884675 · Elscint, Inc. · Apr 1989
MICRODELTA II
K885242 · Siemens Gammasonics, Inc. · Mar 1989
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878 · Philips Medical Systems (Cleveland), Inc. · Sep 1988
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K881013 · Toshiba Medical Systems · Aug 1988