Shimadzu Mobile X-Ray Systems

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K940294 ↗

FDA Product Code

OXO

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Micro-Flow Spectrophotometer Cl-720

  Class I

  FDA 510(k) K801957 Active Cleared 26 Sep 1980

• Shimadzu Mammographic Stand Mr-30

  Class II

  FDA 510(k) K875377 Active Cleared 12 Feb 1988

• Shimadzu Catheterization C-Arm Stand ER-200

  Class II

  FDA 510(k) K875372 Active Cleared 12 Feb 1988

• Shimadzu Whole Body X-Ray CT Scanner Sct-3000TX

  Class II

  FDA 510(k) K875370 Active Cleared 18 May 1988

• Sdu 800 Diagnostic Ultrasound Instrument

  Class II

  FDA 510(k) K890913 Active Cleared 6 Sep 1989

• Shimadzu X-Ray High Voltage Generator UD150K

  Class I

  FDA 510(k) K881795 Active Cleared 1 Jul 1988

See all devices from Shimadzu Precision Instruments, Inc. →

• Are the Shimadzu Mobile X-Ray Systems designed for single-use or reusable applications in clinical settings?

  The Shimadzu Mobile X-Ray Systems are explicitly described as reusable devices intended for use in radiology departments and clinical environments. There is no mention of single-use or sterile packaging in the provided data, so they are not intended for disposable use.

• What types of clinical environments or procedures would these systems be suitable for?

  These systems are image-intensified fluoroscopic X-ray devices designed for portable radiographic imaging, enabling real-time visualization. They are particularly useful for dynamic studies and interventions in settings like radiology departments, where high-resolution imaging is required for procedures such as angiography, orthopedic assessments, or other fluoroscopy-guided interventions.

• How many model variants of the Shimadzu Mobile X-Ray Systems are available, and how can I identify them?

  The data lists multiple model variants, each associated with distinct registration numbers (e.g., 3013099020, 3027339477, etc.). These variants are classified under the product code OXO and regulation number 892.1650, which categorizes them as mobile, image-intensified fluoroscopic X-ray systems. To identify a specific model, refer to the registration number or consult Shimadzu’s documentation.

• What regulatory pathway was followed for FDA clearance of these systems, and when was the original submission received?

  The Shimadzu Mobile X-Ray Systems received FDA 510(k) clearance under the Traditional pathway, with a substantially equivalent (SESE) determination by the Radiology (RA) Advisory Committee. The original submission was received on January 21, 1994, and the decision was made on March 16, 1994. The classification is as a Class II medical device under FDA regulations.