FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TELERAD STAT
K Number: K931795
·
Decision Nov 19, 1993
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
9
Review Days
221
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TELERAD STAT
- K Number
- K931795
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magnetic Research, Inc.
- Date Received
- April 12, 1993
- Decision Date
- November 19, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMD), ordered by most recent decision date.
IIVS INTEGRATED IMAGE VIEWING STATION
FDA 510(k)
FDA Class 1
·Radiology
STENTOR, PAGEVIEW
FDA 510(k)
FDA Class 1
·Radiology
RAYPAX WEB CLINICAL SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
FDA 510(k)
FDA Class 1
·Radiology
SAMSUNG RAYPAX SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Magnetic Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935015 | QUADRATURE SMALL EXTREMITY COIL | May 10, 1994 | Substantially Equivalent |
| K932552 | SPORTS MEDICINE QUADRATURE SHOULDER COIL | Feb 9, 1994 | Substantially Equivalent |
| K932091 | PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL | Dec 14, 1993 | Substantially Equivalent |
| K930991 | BILATERAL TEMPORAL MANDIBULAR JOINT COIL | Jun 18, 1993 | Substantially Equivalent |
| K923881 | QUADRATURE CERVICAL CONTOUR COIL | Nov 5, 1992 | Substantially Equivalent |
| K920227 | QUADRATURE SHOULDER CONTOUR COIL | Aug 24, 1992 | Substantially Equivalent |
| K922006 | QQUADRATURE LUMBAR CONTOUR COIL | Jul 29, 1992 | Substantially Equivalent |
| K905512 | ANTERIOR NECK CONTOUR COIL | Mar 7, 1991 | Substantially Equivalent |