FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIMADZU MOBILE X-RAY SYSTEMS
K Number: K940294
·
Decision Mar 16, 1994
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
81
Applicant Total
23
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SHIMADZU MOBILE X-RAY SYSTEMS
- K Number
- K940294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Precision Instruments, Inc.
- Date Received
- January 21, 1994
- Decision Date
- March 16, 1994
- Product Code
- OXO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXO), ordered by most recent decision date.
Digital C-ARM with 3D
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU MVP Mini C-Arm System
FDA 510(k)
FDA Class 2
·Radiology
OEC One CFD
FDA 510(k)
FDA Class 2
·Radiology
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan VERSA Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Shimadzu Precision Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Sep 6, 1989 | Substantially Equivalent |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Apr 20, 1989 | Substantially Equivalent |
| K884477 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B | Mar 15, 1989 | Substantially Equivalent |
| K875378 | SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION | Nov 16, 1988 | Substantially Equivalent |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Sep 14, 1988 | Substantially Equivalent |
| K881674 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC | Sep 2, 1988 | Substantially Equivalent |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | Jul 1, 1988 | Substantially Equivalent |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | Jul 1, 1988 | Substantially Equivalent |
| K875370 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX | May 18, 1988 | Substantially Equivalent |
| K874946 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 | Mar 3, 1988 | Substantially Equivalent |