IYO · Class II · 21 CFR 892.1560

FDA Product Code IYO: System, Imaging, Pulsed Echo, Ultrasonic

Under FDA product code IYO, pulsed echo ultrasonic imaging systems are cleared for general diagnostic ultrasound applications.

These systems use pulsed sound waves that reflect off tissue interfaces to generate real-time grayscale images of internal anatomy. They form the basis of B-mode (brightness mode) ultrasound used across virtually every medical specialty for anatomical visualization and procedural guidance.

IYO devices are Class II medical devices, regulated under 21 CFR 892.1560 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., General Electric Co. and Advanced Technology Laboratories, Inc..

894
Total
894
Cleared
129d
Avg days
1977
Since
894 devices
265–288 of 894
Cleared Apr 18, 1988
THE ESI-2000 ULTRASOUND UNIT
K874683
Elscint, Inc.
Radiology · 152d
Cleared Mar 31, 1988
TRANSRECTAL PROBE BD65S-TR
K880219
Elscint, Inc.
Radiology · 71d
Cleared Mar 23, 1988
SDR 3500 (PHILIPS PLATINUM +)
K873937
Philips Ultrasound, Inc.
Radiology · 177d
Cleared Mar 15, 1988
NIDEK UP-2000
K880065
Nidek, Inc.
Radiology · 68d
Cleared Jan 11, 1988
SONOLAYER-V, SAL-38B
K872288
Toshiba Medical Systems
Radiology · 209d
Cleared Nov 23, 1987
COLOR FLOW IMAGING
K873096
Advanced Technology Laboratories, Inc.
Radiology · 108d
Cleared Sep 08, 1987
VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
K872307
General Electric Co.
Radiology · 84d
Cleared Aug 19, 1987
SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
K854654
Philips Medical Systems, Inc.
Radiology · 638d
Cleared Aug 17, 1987
OLYMPUS GF-UM2/EU-M2
K872027
Olympus Corp.
Radiology · 83d
Cleared Mar 13, 1987
ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
K870964
Elscint, Inc.
Radiology · 3d
Cleared Jan 09, 1987
SONOLAYER-L, SAL-77B
K863947
Toshiba Medical Systems
Radiology · 91d
Cleared Jan 09, 1987
PACHYMETER SYSTEM V
K864336
CooperVision, Inc.
Radiology · 66d
Cleared Dec 29, 1986
ADA-1000 (ADVANCED DIGITAL ARRAY)
K863780
Diasonics, Inc.
Radiology · 94d
Cleared Dec 18, 1986
STORZ SOLID & ANGLED SOLID CONTACT PROBES
K864398
Storz Instrument Co.
Radiology · 42d
Cleared Nov 24, 1986
7.5 MHZ LINEAR SMALL PARTS PROBE
K863338
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306
K863041
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305
K863043
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
K863096
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Sep 19, 1986
COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF
K862151
Hewlett-Packard Co.
Radiology · 107d
Cleared Sep 04, 1986
CILCO SONOMETRICS DIGICON
K854653
CooperVision, Inc.
Radiology · 289d
Cleared Aug 25, 1986
860 COLOR DOPPLER OR COLORVIEW 860
K861538
Ge Medical Systems Information Technologies
Radiology · 123d
Cleared Jul 24, 1986
ULTRASOUND IMAGING SYSTEM MODEL 280 SL
K860697
Johnson & Johnson Professionals, Inc.
Radiology · 149d
Cleared Jul 16, 1986
ULTRAMARK 1 ULTRASOUND SYSTEM
K862681
Advanced Technology Laboratories, Inc.
Radiology · 1d
Cleared Jul 07, 1986
5.0 MHZ INTRAOPERATIVE ARRAY
K860123
Siemens Medical Solutions USA, Inc.
Radiology · 174d