FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
K Number: K913055
·
Decision Sep 6, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
10
Review Days
59
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Basic Information
- Device Name
- THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
- K Number
- K913055
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atomic Products Corp.
- Date Received
- July 9, 1991
- Decision Date
- September 6, 1991
- Product Code
- IZD
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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Other Clearances by Atomic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915541 | SPECT TABLE, MODEL #056-760 | Jan 17, 1992 | Substantially Equivalent |
| K904187 | ECONOMY C-ARM TABLE, MODEL # 056-005 | Nov 29, 1990 | Substantially Equivalent |
| K904623 | RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 | Nov 6, 1990 | Substantially Equivalent |
| K900851 | DIGITAL IMAGE ENHANCEMENT SYSTEM | May 11, 1990 | Substantially Equivalent |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | Feb 1, 1990 | Substantially Equivalent |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Feb 16, 1989 | Substantially Equivalent |
| K871868 | VENTI-SCAN II | Apr 11, 1988 | Substantially Equivalent |
| K874332 | MRI STRETCHER | Jan 5, 1988 | Substantially Equivalent |
| K790835 | DYNAJECT | Jun 22, 1979 | Substantially Equivalent |