FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K Number: K860472
·
Decision Jul 3, 1986
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
22
Review Days
147
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Basic Information
- Device Name
- NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
- K Number
- K860472
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Diagnostics, Inc.
- Date Received
- February 6, 1986
- Decision Date
- July 3, 1986
- Product Code
- IWE
- 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 |
|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | FDA class 1 | Radiology |
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Other Clearances by Nuclear Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Feb 25, 1994 | Substantially Equivalent |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 2, 1993 | Substantially Equivalent |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Jun 17, 1987 | Substantially Equivalent |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Sep 26, 1986 | Substantially Equivalent |
| K861735 | TIPSEP-TBG ASSAY | Jun 13, 1986 | Substantially Equivalent |
| K852291 | TIPSEP DIGOXIN RIA | Jun 25, 1985 | Substantially Equivalent |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Dec 29, 1983 | Substantially Equivalent |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Apr 18, 1983 | Substantially Equivalent |
| K811558 | TSH-P.E.G. | Jun 18, 1981 | Substantially Equivalent |
| K810906 | TRI-LEVEL NDI CONTROL | Apr 14, 1981 | Substantially Equivalent |