FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
K Number: K893216
·
Decision Sep 5, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
12
Review Days
131
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
- RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
- K Number
- K893216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1925
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Radiation Measurements, Inc.
- Date Received
- April 27, 1989
- Decision Date
- September 5, 1989
- Product Code
- GXX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXX | Block, Test, Ultrasonic Scanner Calibration | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXX), ordered by most recent decision date.
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
FDA 510(k)
FDA Class 1
·Neurology
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Radiation Measurements, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K885223 | RMI SHORT DISTANCE ALIGNMENT DEVICE | Feb 17, 1989 | Substantially Equivalent |
| K873956 | ULTIMETER | Oct 30, 1987 | Substantially Equivalent |
| K873836 | MAMMOGRAPHIC KVP METER MODEL 232 | Oct 16, 1987 | Substantially Equivalent |
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | May 7, 1986 | Substantially Equivalent |
| K834483 | DIGI-X | Mar 5, 1984 | Substantially Equivalent |
| K834607 | ELECTRONIC KVP CASSETTE | Feb 21, 1984 | Substantially Equivalent |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Jan 25, 1984 | Substantially Equivalent |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Jan 25, 1984 | Substantially Equivalent |
| K837033 | ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 | Mar 9, 1983 | Substantially Equivalent |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Dec 2, 1981 | Substantially Equivalent |