← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

ITX — Transducer, Ultrasonic, Diagnostic

DEVICE CLASS
Class II
REGULATION
21 CFR 892.1570
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K250883Olympus Medical Systems Corporation · 510k2025-09-18
K250762Olympus Medical Systems Corporation · 510k2025-07-11
K250524Mendaera, Inc. · 510k2025-07-02
K250469Rivanna Medical, Inc. · 510k2025-06-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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