FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RAY, PORTABLE
K Number: K781276
·
Decision Aug 10, 1978
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
33
Review Days
17
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
- X-RAY, PORTABLE
- K Number
- K781276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Air-Shields, Inc.
- Date Received
- July 24, 1978
- Decision Date
- August 10, 1978
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZL), ordered by most recent decision date.
Portable DR Imaging System
FDA 510(k)
FDA Class 2
·Radiology
RAYMO Mobile X-ray System (Model: RAYMO)
FDA 510(k)
FDA Class 2
·Radiology
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
FDA 510(k)
FDA Class 2
·Radiology
Airbile-100
FDA 510(k)
FDA Class 2
·Radiology
Mobile X-ray unit (!M1)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Air-Shields, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | Oct 7, 1998 | Substantially Equivalent |
| K972309 | JM-102 JAUNDICE METER | Sep 22, 1998 | Substantially Equivalent |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K960980 | ISOLETTE INFANT INCUBATOR | Jul 30, 1996 | Substantially Equivalent |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Jan 17, 1996 | Substantially Equivalent |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | May 3, 1995 | Substantially Equivalent |
| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent |