Cleared Traditional

K003775 - PORTABLE BREAST COMPRESSION DEVICE

K003775 is an FDA 510(k) clearance for PORTABLE BREAST COMPRESSION DEVICE, manufactured by Pem Technologies. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K003775 · Pem Technologies · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
37d
Days
Class 1
Risk

K003775 is an FDA 510(k) clearance for the PORTABLE BREAST COMPRESSION DEVICE. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Pem Technologies (Rockville, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003775

510(k) Number K003775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 12, 2001
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
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 122
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K003775.
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
K023373 · Gvi Technology Partners · Jan 2003
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342 · Anzai Medical Co., Ltd. · Oct 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643 · Health Policy Resorters Group, LLC · May 2002
LUMAGEM SCINTILLATION CAMERA
K993813 · Gamma Medica · Jan 2000
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
K984466 · Dilon Technologies, Inc. · Mar 1999
NOTEBOOK IMAGER
K961104 · Digirad Corp. · May 1997
K003775 · PORTABLE BREAST COMPRESSION DEVICE
Download PDF FDA Summary Pem Technologies