FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K Number: K933103
·
Decision Oct 5, 1993
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
32
Review Days
103
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Basic Information
- Device Name
- DIGITAL IMAGE COMMUNICATIONS SYSTEM
- K Number
- K933103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Analogic Corp.
- Date Received
- June 24, 1993
- Decision Date
- October 5, 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 |
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Other Clearances by Analogic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 | Jun 21, 2007 | Substantially Equivalent |
| K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 | Sep 21, 2005 | Substantially Equivalent |
| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P | Jun 14, 2005 | Substantially Equivalent |
| K043025 | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 | Nov 19, 2004 | Substantially Equivalent |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Aug 6, 2004 | Substantially Equivalent |
| K041376 | C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A | Jul 20, 2004 | Substantially Equivalent |
| K040995 | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 | May 25, 2004 | Substantially Equivalent |
| K033345 | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS | Nov 19, 2003 | Substantially Equivalent |
| K030931 | C3 PATIENT MONITOR | May 9, 2003 | Substantially Equivalent |
| K011304 | OB-1 FETAL MONITOR | May 29, 2001 | Substantially Equivalent |