XERORADIOGRAPHY 125 SYSTEM - MODIFIED
FDA 510(k) clearance K761022 · decided 1976-11-24
Clearance details
- K-number
- K761022
- Device name
- XERORADIOGRAPHY 125 SYSTEM - MODIFIED
- Applicant
- Xeroradiography
- Decision
- Substantially Equivalent
- Date received
- 1976-11-11
- Decision date
- 1976-11-24
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- IXK
- Device class
- 2
- Regulation number
- 892.1630
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (K000159) | Agfa Corp. | 2000-02-16 |
| FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561) | Fujifilm Medical System U.S.A., Inc. | 1994-12-23 |
| DIGORA (K934949) | Orion Corporation Soredex | 1994-02-10 |
| FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (K931002) | Fujifilm Medical System U.S.A., Inc. | 1993-06-08 |
| DIGISCAN 2 (K924459) | Siemens Medical Solutions USA, Inc. | 1992-12-17 |
| FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (K923990) | Fujifilm Medical System U.S.A., Inc. | 1992-12-17 |
| FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE (K924012) | Fujifilm Medical System U.S.A., Inc. | 1992-10-16 |
Recalls involving this device
No recalls on record reference this clearance.