FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
K Number: K860100
·
Decision Apr 22, 1986
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
7
Applicant Total
40
Review Days
102
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
- MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
- K Number
- K860100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Victoreen, Inc.
- Date Received
- January 10, 1986
- Decision Date
- April 22, 1986
- Product Code
- LHO
- 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 |
|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHO), ordered by most recent decision date.
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
ULTIMETER
FDA 510(k)
FDA Class 1
·Radiology
MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
FDA 510(k)
FDA Class 1
·Radiology
MULTI PURPOSE MODEL 76-903
FDA 510(k)
FDA Class 1
·Radiology
BDS-3 BEAM DATA SCANNER
FDA 510(k)
FDA Class 1
·Radiology
RFA-7 RADIATION FIELD ANALYZER
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Victoreen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | Nov 19, 1998 | Substantially Equivalent |
| K974112 | VACUDAP, MODEL 2000, 2001 | Jan 29, 1998 | Substantially Equivalent |
| K973960 | MODEL 37-185 | Jan 14, 1998 | Substantially Equivalent |
| K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | Jul 21, 1997 | Substantially Equivalent |
| K964785 | VERIDOSE DIODES | Jun 13, 1997 | Substantially Equivalent |
| K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 | Jun 6, 1997 | Substantially Equivalent |
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | Dec 9, 1994 | Substantially Equivalent |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | Jul 29, 1994 | Substantially Equivalent |
| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | May 26, 1994 | Substantially Equivalent |