ACCESSPOINT, MED E-MAIL, DICOM READER
FDA 510(k) clearance K963936 · decided 1997-03-31
Clearance details
- K-number
- K963936
- Device name
- ACCESSPOINT, MED E-MAIL, DICOM READER
- Applicant
- Biosound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-01
- Decision date
- 1997-03-31
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biosound
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.