Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1350](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1350) → IYZ — Bed, Scanning, Nuclear

# IYZ · Bed, Scanning, Nuclear

_Radiology · 21 CFR 892.1350 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ

## Overview

- **Product Code:** IYZ
- **Device Name:** Bed, Scanning, Nuclear
- **Regulation:** [21 CFR 892.1350](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1350)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K920962](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K920962.md) | MULTIPLE ACCESSORY TO GAMMA CAMERAS | Nu Age Products | Apr 17, 1992 | SESE |
| [K915541](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K915541.md) | SPECT TABLE, MODEL #056-760 | Atomic Products Corp. | Jan 17, 1992 | SESE |
| [K911691](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K911691.md) | XYZ CRANK IMAGING TABLE | Med-Tron Products, Inc. | Aug 9, 1991 | SESE |
| [K912481](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K912481.md) | ECT CARBON FIBER PALLET, MODIFICATION | Siemens Gammasonics, Inc. | Aug 2, 1991 | SESE |
| [K912286](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K912286.md) | CARDIAC SPECT PALLET | Siemens Gammasonics, Inc. | Aug 2, 1991 | SESE |
| [K912181](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K912181.md) | E-Z LIFT CRANK IMAGING TABLE | Med-Tron Products, Inc. | Jul 17, 1991 | SESE |
| [K912135](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K912135.md) | XY IMAGING TABLE | Med-Tron Products, Inc. | Jul 17, 1991 | SESE |
| [K911564](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K911564.md) | E-Z LIFT IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | Jul 15, 1991 | SESE |
| [K911561](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K911561.md) | XYZ IMAGING TABLE WITH FOOT PUMP | Med-Tron Products, Inc. | Jul 15, 1991 | SESE |
| [K903901](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K903901.md) | SCANNING COT | Med-Tron Products, Inc. | Sep 21, 1990 | SESE |
| [K903767](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K903767.md) | ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL | Siemens Gammasonics, Inc. | Sep 7, 1990 | SESE |
| [K893826](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ/K893826.md) | QRSYSTEMS H.D. NUCLEAR IMAGING TABLE | Qrsystems, Inc. | Aug 2, 1989 | SESE |

## Top Applicants

- Med-Tron Products, Inc. — 6 clearances
- Siemens Gammasonics, Inc. — 3 clearances
- Qrsystems, Inc. — 1 clearance
- Nu Age Products — 1 clearance
- Atomic Products Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYZ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com