FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGI-X
K Number: K834483
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
7
Applicant Total
12
Review Days
90
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
- DIGI-X
- K Number
- K834483
- 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 6, 1983
- Decision Date
- March 5, 1984
- 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
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
FDA 510(k)
FDA Class 1
·Radiology
BDS-3 BEAM DATA SCANNER
FDA 510(k)
FDA Class 1
·Radiology
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 |
| 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 |