Cleared Traditional

K972365 - COMPACT OR COMP-X

K972365 is an FDA 510(k) clearance for COMPACT OR COMP-X, manufactured by Eurotec, S.R.L.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K972365 · Eurotec, S.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
170d
Days
Class 2
Risk

K972365 is an FDA 510(k) clearance for the COMPACT OR COMP-X. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Eurotec, S.R.L. (Scanzorosciate (Bg), IT). The FDA issued a Cleared decision on December 12, 1997 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Eurotec, S.R.L. devices

FDA 510(k) Submission Details - K972365

510(k) Number K972365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date December 12, 1997
Days to Decision 170 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
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 154
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K972365.
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · Shimadzu Corp. · Jun 2000
XR-910
K981466 · Imaging Sciences Intl., Inc. · Jul 1998
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
K973833 · Dynarad Corp. · Dec 1997
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K973712 · Minxray, Inc. · Dec 1997
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · Sterne Equipment Co., Ltd. · Oct 1997
SEALED LEAD ACID BATTERY PACK
K970234 · Portable Power Systems, Inc. · May 1997