FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI SHORT DISTANCE ALIGNMENT DEVICE
K Number: K885223
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
12
Review Days
59
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Basic Information
- Device Name
- RMI SHORT DISTANCE ALIGNMENT DEVICE
- K Number
- K885223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radiation Measurements, Inc.
- Date Received
- December 20, 1988
- Decision Date
- February 17, 1989
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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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 |
| 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 |