FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCESSPOINT, MED E-MAIL, DICOM READER
K Number: K963936
·
Decision Mar 31, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
39
Review Days
181
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Basic Information
- Device Name
- ACCESSPOINT, MED E-MAIL, DICOM READER
- K Number
- K963936
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosound, Inc.
- Date Received
- October 1, 1996
- Decision Date
- March 31, 1997
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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Other Clearances by Biosound, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Jul 9, 1997 | Substantially Equivalent |
| K963262 | ARTOSCAN M | Mar 28, 1997 | Substantially Equivalent |
| K963662 | GALILEO EVOKED POTENTIALRE | Feb 26, 1997 | Substantially Equivalent |
| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 8, 1996 | Substantially Equivalent |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 1, 1996 | Substantially Equivalent |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 1, 1996 | Substantially Equivalent |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent |
| K953579 | TEE PROBE | Feb 2, 1996 | Substantially Equivalent |
| K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Oct 24, 1995 | Substantially Equivalent |