FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIMADZU LATERAL C-ARM MH-31
K Number: K882311
·
Decision Sep 14, 1988
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
23
Review Days
103
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Basic Information
- Device Name
- SHIMADZU LATERAL C-ARM MH-31
- K Number
- K882311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Shimadzu Precision Instruments, Inc.
- Date Received
- June 3, 1988
- Decision Date
- September 14, 1988
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Shimadzu Precision Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940294 | SHIMADZU MOBILE X-RAY SYSTEMS | Mar 16, 1994 | Substantially Equivalent |
| 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 |
| 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 |