FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUCLEAR 700 MEDICINE MECHANICAL POSIT-
K Number: K843716
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
32
Review Days
84
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Basic Information
- Device Name
- NUCLEAR 700 MEDICINE MECHANICAL POSIT-
- K Number
- K843716
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- September 24, 1984
- Decision Date
- December 17, 1984
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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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 |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Jan 23, 1985 | 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 |