Cleared Special

K021527 - SECTRA OSTEOPOROSIS PACKAGE

K021527 is an FDA 510(k) clearance for SECTRA OSTEOPOROSIS PACKAGE, manufactured by Sectra-Imtec AB. The device is a Class 2 Radiology device with product code KGI cleared through the Special 510(k) pathway after a 28-day FDA review.

K021527 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
28d
Days
Class 2
Risk

K021527 is an FDA 510(k) clearance for the SECTRA OSTEOPOROSIS PACKAGE. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Sectra-Imtec AB (Denton, US). The FDA issued a Cleared decision on June 7, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021527

510(k) Number K021527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date June 07, 2002
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KGI Device Classification - Class 2, Special Controls

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
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 - KGI Densitometer, Bone

All 124
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K021527.
CTXA HIP EXTENDED REFERENCE DATA
K030330 · Mindways Software, Inc. · Jun 2003
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554 · Ge Lunar Corp. · Dec 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · Hologic, Inc. · Nov 2002
DEXACARE G4
K021331 · Osteometer Meditech, Inc. · May 2002
CTXA HIP
K002113 · Mindways Software, Inc. · Dec 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917 · Ge Lunar Corp. · Aug 2001
K021527 · SECTRA OSTEOPOROSIS PACKAGE
Download PDF FDA Summary Sectra-Imtec AB