FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
K Number: K844247
·
Decision Jan 23, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
32
Review Days
83
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Basic Information
- Device Name
- ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
- K Number
- K844247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1925
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- November 1, 1984
- Decision Date
- January 23, 1985
- 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.
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
FDA 510(k)
FDA Class 1
·Neurology
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Technicare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854340 | TECHNICARE 720 HPS CT SCANNER | Nov 15, 1985 | Substantially Equivalent |
| K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM | Jul 18, 1985 | Substantially Equivalent |
| K844293 | AUTO DII MULTI FREQUENCY | Feb 13, 1985 | Substantially Equivalent |
| K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- | Dec 17, 1984 | Substantially Equivalent |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | Nov 29, 1984 | Substantially Equivalent |
| K841817 | TECHNICARE 248 SL & 260SL | Aug 17, 1984 | Substantially Equivalent |
| K840860 | CENTAURI CT SCANNER | May 22, 1984 | Substantially Equivalent |
| K840540 | TECHNICARE MODEL 330 | May 9, 1984 | Substantially Equivalent |
| K834486 | TECHNICARE 280 | Apr 13, 1984 | Substantially Equivalent |
| K840390 | TECHNICARE MODEL 1047 | Feb 21, 1984 | Substantially Equivalent |