FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
K Number: K861994
·
Decision Jul 18, 1986
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
14
Review Days
56
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
- MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
- K Number
- K861994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- May 23, 1986
- Decision Date
- July 18, 1986
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPR), ordered by most recent decision date.
DRE Duo
FDA 510(k)
FDA Class 2
·Radiology
AeroDR TX c02
FDA 510(k)
FDA Class 2
·Radiology
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
FDA 510(k)
FDA Class 2
·Radiology
uDR Arria & uDR Aris
FDA 510(k)
FDA Class 2
·Radiology
uDR Aurora CX
FDA 510(k)
FDA Class 2
·Radiology
Definium Tempo Select
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Medicor USA , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | Jun 19, 1986 | Substantially Equivalent |
| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | May 7, 1986 | Substantially Equivalent |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Sep 19, 1985 | Substantially Equivalent |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Jul 1, 1985 | Substantially Equivalent |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Jun 19, 1985 | Substantially Equivalent |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | Nov 27, 1984 | Substantially Equivalent |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Mar 23, 1984 | Substantially Equivalent |
| K840225 | C-ARM CEILING CRANE FT-2 | Mar 22, 1984 | Substantially Equivalent |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Mar 16, 1984 | Substantially Equivalent |
| K823695 | CPM METABOLIC MONITOR | Jan 14, 1983 | Substantially Equivalent |