Cleared Traditional

K001341 - DR5000 DEDICATED CHEST X-RAY SYSTEM

K001341 is the FDA 510(k) clearance for DR5000 DEDICATED CHEST X-RAY SYSTEM by Analogic Corp.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K001341 · Analogic Corp. · Radiology device
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Jun 2000
Decision
36d
Days
Class 2
Risk

K001341 is an FDA 510(k) clearance for the DR5000 DEDICATED CHEST X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

View all Analogic Corp. devices

Submission Details

510(k) Number K001341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2000
Decision Date June 02, 2000
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K001341.
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001
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DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336 · Analogic Corp. · Jun 2000
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201 · Siemens Medical Solutions USA, Inc. · Jun 2000
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · Ge Medical Systems, Inc. · Nov 1999
SILHOUETTE FC
K993090 · Ge Medical Systems, Inc. · Oct 1999