Cleared Traditional

K853008 - SONOLINE SL-2(ULTRASOUND SCANNER)

K853008 is the FDA 510(k) clearance for SONOLINE SL-2(ULTRASOUND SCANNER) by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K853008 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
181d
Days
Class 2
Risk

K853008 is an FDA 510(k) clearance for the SONOLINE SL-2(ULTRASOUND SCANNER). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 181 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K853008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1985
Decision Date January 13, 1986
Days to Decision 181 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 107d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 387
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K853008.
SONOLAYER SAL-55A/55AS
K853739 · Toshiba Medical Systems · Feb 1986
ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN
K853702 · Johnson & Johnson Professionals, Inc. · Feb 1986
SONOLINE LX
K853946 · Siemens Medical Solutions USA, Inc. · Jan 1986
DIASONICS ADA400 ADVANCED DIGITAL ARRAY
K851972 · Diasonics, Inc. · Dec 1985
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
K854135 · Hewlett-Packard Co. · Dec 1985
LINEAR ARRAY PROBE PLB-310M FOR SAL-32B
K853311 · Toshiba Medical Systems · Nov 1985