← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OWB — Interventional Fluoroscopic X-Ray System
Interventional fluoroscopy
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1650
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
35
510(K)/PMA CLEARANCES
510k: 35
0
RECALL ENTRIES
Recent clearances
K253670Philips Medical Systems B.V. · 510k2026-07-10
K252735Pulmera, Inc. · 510k2026-05-22
K252503Canon, Inc. · 510k2026-04-30
K254173Siemens Medical Solutions USA, Inc. · 510k2026-04-24
K253752Siemens Medical Solutions USA, Inc. · 510k2026-04-23
K252229Genoray Co., Ltd. · 510k2026-04-02
K252099Shimadzu Corporation · 510k2026-03-24
K253584Canon Medical Systems Corporation · 510k2026-03-10
Related on SPEQ
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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