Camera, Scintillation (Gamma)
Regulation 892.1100
0510(k)s in 12 months (130 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in IYX
| Company | 510(k)s | Recalls |
|---|---|---|
| General Electric Co. | 15 | 0 |
| Siemens Gammasonics, Inc. | 11 | 0 |
| Adac Laboratories | 6 | 0 |
| Elscint, Inc. | 5 | 0 |
| Medtronic Vascular | 5 | 0 |
| Toshiba Medical Systems | 5 | 0 |
| Medx, Inc. | 4 | 0 |
| Union Carbide Corp. | 4 | 0 |
| Digirad Corp. | 3 | 0 |
| Dilon Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 1981 | K811715 | ROTA CAMERA Siemens Gammasonics, Inc. | IYX |
| Jul 2, 1981 | K811676 | MAXI CAMERA/D General Electric Co. | IYX |
| May 27, 1981 | K811187 | MEDTRONIC A2 CLINICAL IMAGING SYSTEM Medtronic Vascular | IYX |
| May 13, 1981 | K810974 | GAMMA CAMERA Siemens Gammasonics, Inc. | IYX |
| Nov 26, 1980 | K802475 | A2 IMAGE PROCESSING SYSTEM Medtronic Vascular | IYX |
| Aug 20, 1980 | K801654 | MAXI CAMERA 61 General Electric Co. | IYX |
| Aug 20, 1980 | K801653 | MAXI CAMERA 37 General Electric Co. | IYX |
| Jul 21, 1980 | K801368 | A2 IMAGE PROCESSING SYSTEM Medtronic Vascular | IYX |
| Dec 13, 1979 | K791682 | CLEON 720 LARGE FIELD GAMMA CAMERA Union Carbide Corp. | IYX |
| Mar 28, 1979 | K790466 | U-MAT Engineering Dynamics Corp. | IYX |
| Mar 26, 1979 | K790499 | MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER Engineering Dynamics Corp. | IYX |
| Mar 26, 1979 | K790463 | MODU-SET COLLIMOTOR Medtronic Vascular | IYX |
| Jan 26, 1979 | K790081 | CAMERA, CLEON 720 LARGE FIELD GAMMA Union Carbide Corp. | IYX |
| Dec 22, 1978 | K782029 | MAXI CAMERA 400T General Electric Co. | IYX |
| Dec 20, 1978 | K782047 | PROCESSING SYSTEM, A2 IMAGE Medtronic Vascular | IYX |
| Nov 27, 1978 | K781739 | CAMERA, GCA-10A, LOW ENERGY Toshiba Medical Systems | IYX |
| Oct 17, 1978 | K781673 | MAXI-CAMERA 535 General Electric Co. | IYX |
| Jun 27, 1978 | K780969 | GAMMA CAMERA Machlett Laboratories, Inc. | IYX |
| Jun 22, 1978 | K780971 | CLINICAL ACQUISITION MODULE Analytical Development Assoc. Corp. | IYX |
| Jun 2, 1978 | K780855 | GAMMA CAMERA G.D. Searle and Co. | IYX |
| Apr 18, 1978 | K780491 | DATA CAMERA General Electric Co. | IYX |
| Mar 2, 1978 | K780165 | PROCESSOR, VIDEO IMAGE VIP-550 Ohio Nuclear, Inc. | IYX |
| Mar 2, 1978 | K780155 | DUAL CHANNEL PULSE HEIGHT ANALYZER Iso Graphics, Inc. | IYX |
| Jan 26, 1978 | K780060 | CAMERA, GAMMA Ackerman-Schmehl Industries, Inc. | IYX |
| Sep 20, 1977 | K771599 | GAMMA CAMERAS -GXA-301 & GCA-402 Toshiba Medical Systems | IYX |
| Jul 1, 1977 | K770954 | UNIVUE I Union Carbide Corp. | IYX |
| May 10, 1977 | K770753 | PORTA CAMERA IIC General Electric Co. | IYX |
| Apr 5, 1977 | K770531 | UNICAM I Union Carbide Corp. | IYX |
| Feb 28, 1977 | K770343 | MAXICAMERA II General Electric Co. | IYX |
| Dec 6, 1976 | K761159 | PORTACAMERA 11-B General Electric Co. | IYX |
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