FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAMIC WEDGE
K Number: K970564
·
Decision May 12, 1997
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
3
Review Days
88
Basic Information
- Device Name
- DYNAMIC WEDGE
- K Number
- K970564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MITSUBISHI ELECTRONICS AMERICA, INC.
- Date Received
- February 13, 1997
- Decision Date
- May 12, 1997
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
Cranial 4Pi Immobilization
FDA 510(k)
FDA Class 2
·Radiology
MapRT
FDA 510(k)
FDA Class 2
·Radiology
Mobius3D (4.1)
FDA 510(k)
FDA Class 2
·Radiology
DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
FDA 510(k)
FDA Class 2
·Radiology
Klarity SGRT System (ARSG-E1A, ARSG-E3A)
FDA 510(k)
FDA Class 2
·Radiology
Identify (4.0)
FDA 510(k)
FDA Class 2
·Radiology