FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
K Number: K924593
·
Decision Nov 24, 1992
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
111
Review Days
75
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
- DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
- K Number
- K924593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1670
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems, Inc.
- Date Received
- September 10, 1992
- Decision Date
- November 24, 1992
- Product Code
- IXL
- 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 |
|---|---|---|---|
| IXL | Device, Spot-Film | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXL), ordered by most recent decision date.
OPTIMA XR120
FDA 510(k)
FDA Class 2
·Radiology
MD-1835
FDA 510(k)
FDA Class 2
·Radiology
ADVANTX 1824 SPOTFILM DEVICE
FDA 510(k)
FDA Class 2
·Radiology
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
FDA 510(k)
FDA Class 2
·Radiology
AXT 1400 SPOTFILM DEVICE
FDA 510(k)
FDA Class 2
·Radiology
ELITE R/F SPOT FILM DRIVE
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Philips Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093355 | PCR ELEVA 1.2 | Jan 8, 2010 | Substantially Equivalent |
| K090808 | PINNACLE3 SMARTARC | Apr 3, 2009 | Substantially Equivalent |
| K071391 | PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 | Sep 7, 2007 | Substantially Equivalent |
| K063783 | PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A | Apr 27, 2007 | Substantially Equivalent |
| K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN | Jul 21, 2004 | Substantially Equivalent |
| K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN | May 12, 2004 | Substantially Equivalent |
| K040404 | HEARTSTART MRX, MODEL M3535A | May 4, 2004 | Substantially Equivalent |
| K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II | Mar 3, 2004 | Substantially Equivalent |
| K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | Feb 20, 2004 | Substantially Equivalent |
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER | Feb 13, 2004 | Substantially Equivalent |