FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPICS(ME-977)
K Number: K971154
·
Decision Jun 25, 1997
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
8
Review Days
89
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
- MULTIPICS(ME-977)
- K Number
- K971154
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merlin Engineering Works, Inc.
- Date Received
- March 28, 1997
- Decision Date
- June 25, 1997
- 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 Merlin Engineering Works, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974882 | DOWNSCAN LT | May 22, 1998 | Substantially Equivalent |
| K971153 | SPLITSCREEN (ME-975) | Jun 25, 1997 | Substantially Equivalent |
| K970451 | DOWNSCAN 120 | Apr 7, 1997 | Substantially Equivalent |
| K970450 | UPSCAN 120 | Apr 1, 1997 | Substantially Equivalent |
| K954211 | CRISPICS | Dec 5, 1995 | Substantially Equivalent |
| K953398 | UNISCAN | Oct 6, 1995 | Substantially Equivalent |
| K933512 | UPSCAN | Apr 19, 1995 | Substantially Equivalent |