Cleared Traditional

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (K001336) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001336 · Analogic Corp. · Radiology device
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Jun 2000
Decision
36d
Days
Class 2
Risk

K001336 is an FDA 510(k) clearance for the DR9000 DIGITAL RADIOGRAPHY 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 K001336 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
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 115
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K001336.
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K050704 · General Electric Co. · Apr 2005
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201 · Siemens Medical Solutions USA, Inc. · Jun 2000
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K992066 · GE Medical Systems · Aug 1999
FV-RF
K984111 · Philips Medical Systems (Cleveland), Inc. · Dec 1998