FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE MIMICKING ULTRASOUND PHANTOMS
K Number: K834482
·
Decision Jan 25, 1984
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
4
Applicant Total
12
Review Days
41
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Basic Information
- Device Name
- TISSUE MIMICKING ULTRASOUND PHANTOMS
- K Number
- K834482
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radiation Measurements, Inc.
- Date Received
- December 15, 1983
- Decision Date
- January 25, 1984
- Product Code
- IXF
- 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 |
|---|---|---|---|
| IXF | Test-Pattern, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXF), ordered by most recent decision date.
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1.5` FOCAL SPOT RESOLUTION PATTERN
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Other Clearances by Radiation Measurements, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893216 | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | Sep 5, 1989 | Substantially Equivalent |
| 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 |
| 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 |