FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESTILIX 1690
K Number: K843926
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
20
Review Days
51
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Basic Information
- Device Name
- PRESTILIX 1690
- K Number
- K843926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- October 27, 1984
- Decision Date
- December 17, 1984
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXR), ordered by most recent decision date.
VISION R/F TILTING TABLE
FDA 510(k)
FDA Class 2
·Radiology
LEGACY/LEGACY-D TABLE
FDA 510(k)
FDA Class 2
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CAP-35B III/CINE 275
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS EASY DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
FDA 510(k)
FDA Class 2
·Radiology
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Cgr Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843235 | STENOSCOP | Nov 8, 1984 | Substantially Equivalent |
| K843985 | SUSPENSION 7 | Nov 5, 1984 | Substantially Equivalent |
| K841649 | MAXIMAX - 4 | Jun 5, 1984 | Substantially Equivalent |
| K833223 | SONEL 3000A | May 9, 1984 | Substantially Equivalent |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | Dec 29, 1983 | Substantially Equivalent |
| K833941 | ORION | Dec 29, 1983 | Substantially Equivalent |
| K833846 | PROCESS 100 ST | Dec 16, 1983 | Substantially Equivalent |
| K837412 | SATURNE I LINEAR ACCELERATOR | Jun 28, 1983 | Substantially Equivalent |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | Jun 28, 1983 | Substantially Equivalent |
| K837336 | VERASUN RADIATION THERAPY SIMULATION SYSTEM | Apr 29, 1983 | Substantially Equivalent |