FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
K Number: K900697
·
Decision May 11, 1990
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
12
Review Days
87
Basic Information
- Device Name
- CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
- K Number
- K900697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- NUCCARDIAC SOFTWARE, INC.
- Date Received
- February 13, 1990
- Decision Date
- May 11, 1990
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by NUCCARDIAC SOFTWARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K972509 | CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER | Sep 8, 1997 | Substantially Equivalent |
| K970288 | CLINICAL DIAGNOSTIC SOFTWARE | Apr 24, 1997 | Substantially Equivalent |
| K944720 | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION | Dec 23, 1994 | Substantially Equivalent |
| K942363 | CEQUAL-QUANTITATIVE ANALYSIS | Sep 16, 1994 | Substantially Equivalent |
| K932701 | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS | Mar 29, 1994 | Substantially Equivalent |
| K922671 | CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS | Aug 11, 1992 | Substantially Equivalent |
| K915644 | CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS | Feb 27, 1992 | Substantially Equivalent |
| K914296 | CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC | Nov 27, 1991 | Substantially Equivalent |
| K905222 | CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0 | Dec 26, 1990 | Substantially Equivalent |
| K892397 | MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS | Oct 27, 1989 | Substantially Equivalent |