FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DICOMVIEW
K Number: K954479
·
Decision Feb 21, 1996
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
6
Review Days
148
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Basic Information
- Device Name
- DICOMVIEW
- K Number
- K954479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heartlab, Inc.
- Date Received
- September 26, 1995
- Decision Date
- February 21, 1996
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Heartlab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050858 | ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM | Jun 29, 2005 | Substantially Equivalent |
| K050228 | AGFA HEARTLAB CARDIOVASCULAR | Feb 18, 2005 | Substantially Equivalent |
| K042042 | ULTRASOUND CAPTURE SYSTEM | Sep 21, 2004 | Substantially Equivalent |
| K040896 | MODIFICATION TO ENCOMPASS | Jul 16, 2004 | Substantially Equivalent |
| K954860 | ECHONET | Dec 21, 1995 | Substantially Equivalent |