Cleared Traditional

K884674 - APEX 415 ANGER CAMERA

K884674 is the FDA 510(k) clearance for APEX 415 ANGER CAMERA by Elscint, Inc.. It is a Class 1 Radiology device (product code IYX) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K884674 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
160d
Days
Class 1
Risk

K884674 is an FDA 510(k) clearance for the APEX 415 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 17, 1989 after a review of 160 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 K884674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date April 17, 1989
Days to Decision 160 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
53d slower than avg
Panel avg: 107d · This submission: 160d
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 K884674.
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
K904050 · Philips Medical Systems (Cleveland), Inc. · Dec 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689 · Adac Laboratories · Apr 1990
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672 · Elscint, Inc. · Apr 1989
APEX 609R ANGER CAMERA
K884675 · Elscint, Inc. · Apr 1989
APEX 215M MOBILE ANGER CAMERA
K884673 · Elscint, Inc. · Apr 1989
MICRODELTA II
K885242 · Siemens Gammasonics, Inc. · Mar 1989